Drug Information Update · 2019. 9. 26. · lead to intraocular infections such as endophthalmitis...

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Drug Information Update September 2019

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TABLE OF CONTENTS NEWLY AVAILABLE GENERICS ................................................................. 2

NEW DRUG ENTITIES/STRENGTHS/COMBINATIONS ............................... 3

NEW INDICATIONS (EXISTING DRUGS) .................................................... 5

FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS .............................. 6

STUDIES AND RECENT TOPICS ............................................................... 12

RECALLS ................................................................................................ 16

CURRENT DRUG SHORTAGES ................................................................ 25


NEWLY AVAILABLE GENERICS

GENERIC DRUG NAME STRENGTH & DOSAGE FORM

GENERIC MANUFACTURER BRAND NAME

BUPIVACAINE HCL/PF 2.5 MG/ML, 5 MG/ML AMPULE

AREVA PHARMACEUTICALS SENSORCANE-MPF

EPINEPHRINE 0.15 MG/0.3 ML AUTO INJECTOR

MYLAN SPECIALTY, TEVA USA EPIPEN JR

HALCINONIDE 0.1 % CREAM MYLAN HALOG

TRIAMTERENE 50 MG, 100 MG CAPSULE

PRASCO LABS, TRUPHARMA LLC DYRENIUM

FOSAPREPITANT DIMEGLUMINE 150 MG VIAL

DR. REDDY'S LAB, APOTEX CORP,

NOVADOZ PHARMAC, MYLAN INSTITUTI, FRESENIUS KABI

EMEND

AMINOCAPROIC ACID 250 MG/ML SOLUTION AMNEAL PHARMACEUTICALS AMICAR

VANCOMYCIN HCL 50 MG/ML SOLN RECON

ANI PHARMACEUTICALS FIRVANQ

ARSENIC TRIOXIDE 12 MG/6 ML VIAL ZYDUS PHARMACEUTICALS TRISENOX


NEW DRUG ENTITIES/STRENGTHS/COMBINATIONS

DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES

DRUGS TO TREAT ERECTILE

DYSFUNCTION (ED)

TRI-MIX (PAPVRN-PHNTLMN-PGE1)

PAPAVER/ PHENTOLAMINE/

ALPROSTADIL

150 MG-5 MG- 50 MCG VIAL

NEW COMBINATION

OPHTH. VEGF-A RECEPTOR ANTAG.

RCMB MC ANTIBODY

BEVACIZUMAB BEVACIZUMAB 3.25 MG/0.13 ML SYRINGE NEW STRENGTH

ANTINEOPLASTIC SYSTEMIC ENZYME

INHIBITORS ROZLYTREK ENTRECTINIB 100 MG, 200 MG

CAPSULE NEW ENTITY

ANTINEOPLASTIC SYSTEMIC ENZYME

INHIBITORS INREBIC FEDRATINIB

DIHYDROCHLORIDE 100 MG CAPSULE NEW ENTITY

ANTISERA CUVITRU IMMUN GLOB G (IGG)/GLY/IGA

OV50 10 G/50 ML VIAL NEW STRENGTH

PLEUROMUTILIN DERIVATIVES XENLETA LEFAMULIN

ACETATE

600 MG TABLET, 150MG/15 ML

VIAL NEW ENTITY

JANUS KINASE (JAK) INHIBITORS RINVOQ ER UPADACITINIB 15 MG TABLET ER

24H NEW ENTITY

ACNE AGENTS,TOPICAL NUCARACLIN PAK CLIND/OTN/OCSAL

/O-CRL/OXB/TITN 1 %-SPF 50 KIT

GEL-LT Rx + OTC

ACNE AGENTS,TOPICAL NUCARARXPAK

CLIN-BEN-OTN-OCSL-OCT-OXY-

TITN

1 %-2.5 % KIT GEL-LT Rx + OTC

PROTEIN STABILIZERS VYNDAMAX TAFAMIDIS 61 MG CAPSULE NEW ENTITY


DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES NSAID AND

TOPICAL IRRITANT COUNTER-

IRRITANT COMB

INFLATHERM (DICLOFENAC-

MENTHOL)

DICLOFENAC/ MENTHOL/ CAMPHOR

75 MG-3%-3% KIT GLTBDR Rx + OTC

ANTICONVULSANT -BENZODIAZEPINE

TYPE NAYZILAM MIDAZOLAM 5 MG/SPRAY NEW DOSAGE

FORM

AGENTS TO TREAT HYPOGLYCEMIA,

HYPERGLYCEMICS GVOKE SYRINGE GLUCAGON

0.5 MG/0.1 ML, 1 MG/0.2 ML

SYRINGE, AUTO INJECTOR

NEW DOSAGE FORM

MYDRIATICS TROPICAMIDE-PHENYLEPHRINE

PHENYLEPHRINE/ TROPICAMIDE IN

WATER 2.5 %-1 % DROPS

NEW COMBINATION; COMPOUNDED OPHTHALMIC

FROM OUTSOURCE FACILITY

ANTIMIGRAINE PREPARATIONS TOSYMRA SUMATRIPTAN 10 MG NASAL

SPRAY NEW STRENGTH


NEW INDICATIONS (EXISTING DRUGS)

TALTZ® August 26, 2019 INDIANAPOLIS, Aug. 26, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA). Source: Eli Lilly and Company MYOBLOC® August 26, 2019 LOUISVILLE, KY, August 26, 2019 -- US WorldMeds, LLC announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for MYOBLOC® (rimabotulinumtoxin B) injection for the treatment of chronic sialorrhea in adults. Source: US WorldMeds, LLC OFEV® September 6, 2019 Ridgefield, Conn., September 6, 2019 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved Ofev® (nintedanib) as the first and only medicine to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Ofev is already approved in the U.S. and more than 70 countries for the treatment of patients living with idiopathic pulmonary fibrosis (IPF), and has been shown to slow IPF progression by reducing the annual rate of decline in lung function, as measured by forced vital capacity (FVC). Source: Boehringer Ingelheim NUCALA® September 12, 2019 London UK, September 12,2019 – GlaxoSmithKline (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for use in children as young as six years old who are living with severe eosinophilic asthma. Nucala is the only targeted biologic to be approved for the condition in the six to 11-year age group in the US. Source: GlaxoSmithKline


FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS

Sterile Compounded Drug Products by AmEx Pharmacy: Recall - FDA requests recall of sterile compounded drug products and reminds patients and health professionals to stop using due to potential risks [Posted 08/27/19] ISSUE: An FDA inspection of AmEx Pharmacy’s facility found conditions that could cause the company’s drugs to become contaminated or otherwise pose risks to patients. Administration of a non-sterile drug intended to be sterile presents the risk of infection. Intraocular medications which are not sterile can lead to intraocular infections such as endophthalmitis which, depending on the infecting microorganism, can lead to a loss of partial or total permanent visual function (i.e., no light perception). RECOMMENDATIONS: The FDA urges consumers to stop using these drugs and to dispose of them immediately. Patients who have concerns about receiving any drug produced by AmEx Pharmacy or who observe signs of an infection after using these medicines should contact their health professional. Health professionals should immediately check their medical supplies, quarantine any drugs intended to be sterile and prepared by AmEx Pharmacy, and not administer or provide them to patients. The FDA urges health professionals who obtained drugs from AmEx Pharmacy to make alternative arrangements to obtain medications from sources that adhere to proper quality standards. The FDA has received reports of adverse events associated with the use of AmEx Pharmacy’s drugs. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online. • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the

address on the form, or submit by fax to 1-800-FDA-0178. Source: U.S. Food and Drug Administration (FDA) Hepatitis C Medicines [Mavyret (glecaprevir and pibrentasvir), Zepatier (elbasvir and grazoprevir), and Vosevi (sofosbuvir, velpatasvir, and voxilaprevir)]: Drug Safety Communication – Rare Occurrence of Serious Liver Injury in Some Patients with Advanced Liver Disease [Posted 08/28/19] ISSUE: FDA has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic Hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. FDA identified 63 cases of worsening liver function called liver decompensation with regimens Mavyret, Zepatier, and Vosevi to treat Hepatitis C. Some of these cases led to liver failure and death. Most of these patients had moderate to severe liver impairment and should not have been prescribed these medicines.


RECOMMENDATION: Health professionals should continue to prescribe Mavyret, Zepatier, or Vosevi as indicated in the prescribing information for patients without liver impairment or with mild liver impairment (Child-Pugh A). Mavyret and Zepatier should not be prescribed in patients with any history of prior hepatic decompensation. Vosevi is indicated for patients who have previously failed certain other Hepatitis C Virus treatments and is not recommended in patients with any history of hepatic decompensation unless the benefits outweigh the risk of liver injury, liver failure or death. Patients should be aware that the risk of serious liver injury is rare. However, patients should contact a health professional right away if they develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools as these may be signs of liver injury. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


address on the form, or submit by fax to 1-800-FDA-0178. Source: U.S. Food and Drug Administration (FDA) Takeda Issues US Recall of NATPARA® (parathyroid hormone) for Injection Due to the Potential for Rubber Particulate [Posted 09/05/19] Takeda Pharmaceutical Company Limited (“Takeda”) today announced that the company is issuing a US recall for all doses of NATPARA® (parathyroid hormone) for Injection (25 mcg, 50 mcg, 75 mcg, and 100 mcg). This recall is being conducted after discussions with the FDA and is effective immediately due to a potential issue related to rubber particulates originating from the rubber septum of the NATPARA cartridge. During the 14-day NATPARA treatment period, the septum is punctured by a needle each day to obtain the daily dosage of NATPARA solution. When the septum is repeatedly punctured, it is possible that small rubber fragments may detach into the cartridge. With patient safety as the company’s main priority, Takeda is communicating directly with healthcare professionals, patients, and specialty pharmacies in the US regarding the actions required as a result of the recall. Consistent with the product labeling, Takeda is alerting NATPARA patients and prescribers that discontinuing NATPARA abruptly can cause a sharp decrease in blood calcium levels (severe hypocalcemia) which can result in serious health consequences. It is critically important that patients contact their prescribing healthcare provider to discuss their individual treatment plan and ensure close supervision, including frequent monitoring of blood calcium levels and close titration of active vitamin D and calcium supplements upon stopping NATPARA to avoid low blood calcium (hypocalcemia). The safety profile of NATPARA remains consistent with the product label. Takeda is working closely with regulatory agencies in relevant markets outside of the US where NATPAR/A is available. NATPAR/A continues to be available in these markets.


NATPARA, a recombinant human protein with the full length 84–amino–acid sequence of endogenous parathyroid hormone (PTH), is currently approved in the US as the only adjunctive treatment for adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone (calcium and vitamin D). Takeda is committed to supply integrity, and we are working closely with the FDA to resolve the issue and resume supply as soon as possible. The financial impact of the recall is currently being assessed in conjunction with the remediation plan. Healthcare providers with medical-related questions or other questions about the NATPARA recall should contact Takeda Medical Information at +1-800-828-2088 and select Option 2. Patients in the US with questions about the NATPARA recall should contact OnePath at +1-866-888-0660. For full prescribing information, including warnings and precautions, please visit https://www.shirecontent.com/PI/PDFs/Natpara_USA_ENG.pdf.External Link Disclaimer Adverse reactions or quality problems experienced with the use of this product may be reported to the US FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then

complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 Source: U.S. Food and Drug Administration (FDA) Hospira, Inc., Issues a Voluntary Nationwide Recall for one lot of BACTERIOSTATIC WATER for Injection, USP, due to a Potential Lack of Sterility Assurance [Posted 09/06/19] Hospira, Inc., a Pfizer company, is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the Hospital/Retail level. Hospira initiated this recall due to lack of confirmation of sterilization for some vials from this lot. In the event that impacted product is administered to a patient, there is an increased risk that severe adverse events such as invasive bacterial infection, including bacterial meningitis, septicemia, and limited adverse events such as fever, chills, malaise, and cutaneous abscess may occur. To date, Hospira has not received reports of any such adverse events associated with this issue for this lot. BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. It is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial is packaged as described below. Product was distributed in the U.S. and Puerto Rico to Hospitals/Retailers from March 2018, to April 2018.


NDC Lot Number Expiration Date Presentation Configuration/Count

Vial: 0409-3977-01 Carton: 0409-3977-03

W20308 01 DEC 2019 30 mL, Multiple dose 4 x 25 x 30mL vials

Hospira, Inc., places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Hospira is notifying its direct customers via a recall letter to arrange for return of any recalled product. Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine immediately. Inform Healthcare Professionals in your organization of this recall. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday. For clinical inquiries please contact Pfizer using the below information.

Contact Contact Information Areas of Support

Pfizer Medical Information 1-800-438-1985, option 3 (9am to 5pm ET Monday through Friday)

For Medical questions regarding this product

Pfizer Drug Safety 1-800-438-1985, option 1 (24 hours a day 7 days per week)

To report adverse events or product complaints

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.


complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 Source: U.S. Food and Drug Administration (FDA) Darmerica LLC Issues Voluntary Nationwide Recall of Quinacrine Dihydrochloride Due to a Labeling Error [Posted 09/12/19] Darmerica LLC is voluntarily recalling two lots, DR4654A and DL4654A, of Quinacrine Dihydrochloride, bulk API powder packaged in Amber HDPE Bottles to the consumer level. This product is being recalled due to a label mix-up. Product intended for further compounding use by pharmacies labeled as Quinacrine API was tested and identified as Artemisinin API. Artemisinin and its semisynthetic derivatives are a group of drugs used against malaria. Receiving artemisinin rather than quinacrine could lead to deterioration of disease that is being treated, serious adverse reactions, due to prolonged exposure to artemisinin, which would need medical or surgical intervention as well as mistaken evaluation and remediation of adverse reactions. To date, Darmerica LLC has not received any reports of adverse events related to this recall.


The product is used as an antiprotozoal, antirheumatic, intrapleural sclerosing agent and was packaged in Amber HDPE bottles. The affected Quinacrine Dihydrochloride lots include the following lot numbers, DR4654A and DL4654A, and expiration date of April 27, 2021. The product can be identified by the label, as illustrated below. Quinacrine Dihydrochloride was distributed Nationwide to 14 Compounding Pharmacies. Darmerica LLC is notifying its distributors and customers by e-mail and telephone and is arranging for return of all recalled products. Compounding Pharmacies that have Quinacrine Dihydrochloride which is being recalled should stop compounding and return it to Darmerica LLC. Compounding Pharmacies should probably initiate their own recalls if they manufactured/distributed product using these two lots. Compounding Pharmacies with questions regarding this recall can contact Darmerica LLC by telephone at 407-766-9092 or [email protected] (Monday to Friday, 9am to 5pm), Eastern Standard Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.


complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 Source: U.S. Food and Drug Administration (FDA) Zantac (ranitidine): Safety Information - NDMA Found in Samples of Some Ranitidine Medicines [Posted 09/13/2019] ISSUE: FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. BACKGROUND: Ranitidine is an over-the-counter (OTC) and prescription drug. Ranitidine is an H2 (histamine-2) blocker, which decreases the amount of acid created by the stomach. Over-the-counter Ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach. Prescription Ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease. The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines. RECOMMENDATION: The FDA is not calling for individuals to stop taking ranitidine at this time; however, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. People taking OTC ranitidine could consider using


other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the

address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 Source: U.S. Food and Drug Administration (FDA) KRS Global Biotechnology, is voluntarily recalling all lots of unexpired human and animal drugs intended to be sterile to the consumer level. The products are being recalled due to lack of assurance of sterility. [Posted 09/13/19] Administration of a drug product intended to be sterile that is not sterile could result in serious infections which may be life-threatening. To date, KRS Global Biotechnology, has not received any reports of adverse events related to this recall. RECOMMENDATION: Consumers should contact their physician or healthcare provider if they have any of these recalled products and if they are experiencing any problems that may be related to taking or using these drug products. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


address on the form, or submit by fax to 1-800-FDA-0178. Source: U.S. Food and Drug Administration (FDA)


STUDIES AND RECENT TOPICS

New Study Addresses Levothyroxine Dosing Concern August 22, 2019 The question of generic equivalency of levothyroxine products has remained unanswered for several decades. But a new study led by Mayo Clinic researchers found that for patients with predominantly benign thyroid disease and newly treated hypothyroidism, there were no differences in cardiovascular event risks between patients treated with brand or generic levothyroxine. Source: pharmacist.com Metabolic Changes May Predict Anthracycline Cardiotoxicity August 22, 2019 Asnani et al studied cardiotoxicity from breast cancer agents in a case-control study. Anthracyclines and trastuzumab are effective medications used to treat breast cancer, but their use is limited at times due to the severe side effect of cardiotoxicity, which is dose-dependent. About 10% to 20% of patients who have been treated with these agents experience cardiotoxicity within a couple of years after finishing treatment. When an anthracycline and trastuzumab are combined, the risk of cardiotoxicity increases greatly. Source: uspharmacist.com Does HHS Have Zero Negotiating Power in Drug Pricing? August 22, 2019 The Senate Finance Committee recently unveiled a bipartisan bill to lower drug prices for seniors. In the House, Speaker Nancy Pelosi’s latest draft of drug price legislation would also allow Medicare to negotiate lower drug prices directly with manufacturers. This seems like just the latest episode of annual outrage over drug pricing transparency. It was exactly one year ago that house members introduced The Medicare Negotiation and Competitive Licensing Act, aimed at allowing the government to negotiate drug prices with manufacturers. Source: medcitynews.com FDA Says Widening Probe on Generic Drug Impurities August 28, 2019 (Reuters) - The U.S. Food and Drugs Administration said on Wednesday it was expanding its investigation into impurities in U.S. generic drugs beyond a class of medicines for high blood pressure known as angiotensin II receptor blockers (ARBs). Source: reuters.com


Tramadol Use Linked to Increase Hypoglycemia August 28, 2019 Investigators from the University of California San Diego have found that a common opioid, often prescribed due to its potential for fewer side effects, could increase a patient’s risk of developing hypoglycemia. Source: mdmag.com AstraZeneca Lupus Drug Shows Promise after Set-Back Last Year August 29, 2019 AstraZeneca Plc said on Thursday its experimental drug to treat moderate-to-severe lupus met the main goal in a late-stage study, an encouraging sign after it failed to meet its main target in the final stage of another trial last year. Source: reuters.com Fresenius Limits Heparin As Shortages of Blood Thinner Persist September 2, 2019 Swine fever that has killed millions of pigs in China and triggered a squeeze on supplies of heparin has forced one of its largest manufacturers to begin limiting allocations of the treatment. Source: fiercepharma.com Some Biologics Associated With Increased Body Weight in Patients with Psoriasis September 4, 2019 Treatment with tumor necrosis factor-inhibitors (TNFi) was associated with significant increases in body weight and body mass index (BMI), according to study data published in the Journal of the American Academy of Dermatology. Source: dermatologyadvisor.com Weight loss possible with psychiatric drugs September 5, 2019 Even overweight and obese people who take certain psychiatric drugs associated with weight gain may be able to shed excess pounds by focusing on healthy eating and exercise habits, a recent study suggests. Researchers followed 17,519 obese and overweight adults enrolled in a weight loss program focused on lifestyle changes at Wharton Medical Clinic in Ontario, Canada. Nearly one quarter of patients were


taking at least one antidepressant or antipsychotic medication, some of which have weight gain as a side effect. Source: reuters.com 70 Million Flu Vaccines Delayed This Year, According To CDC September 5, 2019 Doctors are preparing for delays for this season's flu vaccine as formulation changes led at least one major manufacturer to ship its supply later than planned. According to a notification by the American Academy of Pediatrics, Sanofi Pasteur, the largest company that exclusively produces vaccines, delayed delivery of the flu vaccine by three to four weeks. Source: newsweek.com AstraZeneca’s Imfinzi Prolongs Survival in Aggressive Lung Cancer September 9, 2019 AstraZeneca’s cancer treatment Imfinzi has been shown to prolong survival in a particularly aggressive type of lung cancer by close to three months, as the British drugmaker holds its ground in a crowded field against rival immunotherapy drugs. Source: reuters.com Health experts back treatment for kids with peanut allergy September 13, 2019 Government experts on Friday backed an experimental treatment for children with peanut allergies that could become the first federally approved option for preventing life-threatening reactions. Source: apnews.com Civica Rx pens another deal for drug in short supply September 13, 2019 Civica Rx, a not-for-profit drug company with $100 million in funding that aims to combat drug shortages, has inked its next deal with Exela Pharma Sciences to supply its membership of hospitals with sodium bicarbonate injections. Source: healthexec.com Anakinra Shows Benefits in Cytokine Storm- Treatment success seen only with underlying autoimmune disease, not malignancy September 17, 2019


The interleukin (IL)-1 receptor antagonist anakinra (Kineret) showed promise in critically ill children who develop the often-lethal condition known as secondary hemophagocytic lymphohistiocytosis (sHLH)/macrophage activation syndrome (MAS), a retrospective single-center study found. Source: medpagetoday.com GSK's over-the-counter nicotine oral spray gets FDA panel backing September 18, 2019 Mishra An independent expert panel to the U.S. Food and Drug Administration on Wednesday recommended approval of GlaxoSmithKline Plc’s over-the-counter nicotine oral spray that aims to help smokers quit their addiction. Source: reuters.com


RECALLS

Product Type Product Description Classification Code Info Reason for Recall Recalling

Firm Drug Clear eyes REDNESS RELIEF

(Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye

drops, packaged in a) 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) 1 FL OZ (30 mL)

bottle (UPC 6 78112 25419 4); c) 0.2 FL OZ (6 mL) bottle,

Handy Pocket Pal (UPC 6 78112 25418 7); Distributed by Medtech Products Inc.,

Tarrytown, NY 10591; A Prestige Brands Company.

Class II

Lot #: a) 16195, Exp 07/19; 16211,

16216, Exp 08/19; b) 16205, Exp

07/19; 16211, Exp 08/19; c) 16192,

16203, Exp 07/19; 16242, Exp 09/19; 16280, 16285, Exp 10/19; 16300, Exp 11/19; 16336, Exp

12/19; 17002, 17012, Exp 01/20; 17051, Exp 02/20; 17130, Exp 04/20; 17147, Exp 05/20

CGMP Deviations: concerns

regarding the sufficiency of

Quality Assurance controls over

critical systems in the manufacturing facility that could

impact the product quality of

the finished products.

Medtech Products,

Inc.

Drug Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline

hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL

OZ (6 mL) bottle, Dist. by Lil' Drug Store Products Inc., 1201

Continental Place NE, Cedar Rapids, IA 52402; Medtech Products Inc., Tarrytown, NY 10591, UPC 7 92554 70103 7.

Class II

Lot #: 16321, Exp 11/19; 16336, Exp 12/19; 17012, Exp

01/20; 17034, 17051, Exp 02/20; 17147, Exp 05/20







Medtech Products,

Inc.

Drug Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride

0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle,

Distributed by Medtech Products Inc., Tarrytown, NY

10591, A Prestige Brands Company, UPC 6 78112 65920

3.

Class II

Lot #: 16302, Exp 11/19; 16331,

16344, Exp 12/19; 17011, 17016, Exp

01/20.






Medtech Products,

Inc.



Firm the finished

products. Drug Clear eyes MAXIMUM REDNESS

RELIEF (Glycerin 0.5%, Naphazoline hydrochloride

0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, Distributed by

Medtech Products Inc., Tarrytown, NY 10591, A

Prestige Brands Company, UPC 6 78112 66577 8.

Class II

Lot #: 16234, 16247, Exp 08/19; 16286, Exp 10/19; 16314, Exp 11/19







Medtech Products,

Inc.

Drug Clear Eyes Assorted IRC Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline

hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) Clear

eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%,

Naphazoline hydrochloride 0.03%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 66577 8); and c) Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride

0.012%, Zinc Sulfate 0.25%), 0.5 FL OZ (15 mL) bottle (UPC 6

78112 65920 3); Distributed by Medtech Products Inc.,

Tarrytown, NY 10591, A Prestige Brands Company,

display UPC 6 78112 10452 9.

Class II

Lot #: Display 17E23A, Exp 12/19;

lot and expiry for individual products within this display

are captured in each individual product Code Information







Medtech Products,

Inc.

Drug Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick

Display; each display contains 12 each of a) Clear eyes

MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline

hydrochloride 0.03%) eye

Class II

Lot #: Display 17C30A, Exp 10/19;


are captured in each individual




critical systems in

Medtech Products,

Inc.



Firm drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577 8); and b) Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride

0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle,

(UPC 6 78112 65920 3); Distributed by Medtech

Products Inc., Tarrytown, NY 10591, A Prestige Brands

Company, case UPC 00678112105434.

product Code Information

the manufacturing facility that could



Drug Clear Eyes Assorted Sidekick Floor Stand Display; each

display contains 6 each of a) Clear eyes REDNESS RELIEF

(Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye

drops, 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) Clear

eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%,

Naphazoline hydrochloride 0.03%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 66577 8); and c) Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride

0.012%, Zinc Sulfate 0.25%), 0.5 FL OZ (15 mL) bottle (UPC 6

78112 65920 3); Distributed by Medtech Products Inc.,

Tarrytown, NY 10591, A Prestige Brands Company, case

UPC 00678112106905.

Class II

Lot #: Display 17E12A, Exp 09/19;









Medtech Products,

Inc.

Drug Clear Eyes Redness Relief Club Pack Display; each display

contains 18 3-Pack bottles (UPC 6 78112 10552 6) of Clear eyes

REDNESS RELIEF (Glycerin 0.25%, Naphazoline

hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle

Class II

Lot #: 3-pack Q16299D2, Exp

07/19; Q162300D1, Q16260B1, Q16261B1, Q16263B1, Q16301D1, Q16302D1,




critical systems in the manufacturing

Medtech Products,

Inc.



Firm (individual bottle UPC 6 78112

25415 6); Distributed by Medtech Products Inc.,

Tarrytown, NY 10591, A Prestige Brands Company.

Q16303D1, Q16308D1, Q16309D1, Q16336D1, Q16337D1, Q16340D1, Q16342D1, Q16343D1,

Q16344D1, Exp 08/19; lot and

expiry for individual products within this display


facility that could impact the

product quality of the finished

products.

Drug Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand

Display; each display contains 12 each of Clear eyes

MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc

Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6

78112 65920 30; Distributed by Medtech Products Inc.,

Tarrytown, NY 10591, A Prestige Brands Company, case

UPC 10678112106995.

Class II

Lot #: 16331, 16344, EXP 12/19







Medtech Products,

Inc.

Drug Clear Eyes Maximum Redness Relief Club Pack Display; each

display contains 18 3-Pack bottles (UPC 6 78112 10859 6)

of Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%,

Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577

8); Distributed by Medtech Products Inc., Tarrytown, NY

Class II

Lot #: Q16322M1, Q16323M1, Q16323M2,

Q16326M1, Exp 08/19; lot and

expiry for individual products within this display







Medtech Products,

Inc.



Firm 10591, A Prestige Brands

Company. the finished

products. Drug Clear Eyes Maximum Itchy Eye

Relief Sidekick Floor Stand Display; each display (case UPC 10678112736383) contains 12 each of Clear eyes MAXIMUM

ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline

hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL

OZ (15 mL) bottle, (UPC 6 78112 65920 3), Distributed by

Medtech Products Inc., Tarrytown, NY 10591, A

Prestige Brands Company.

Class II

Lot #: 16331, 16344, Exp 12/19







Medtech Products,

Inc.

Drug Clear Eyes Redness Relief Handy Pocket Pal Club Pak

Display; each display (case UPC 30300742541283) contains 48

each of Clear eyes REDNESS RELIEF (Glycerin 0.25%,

Naphazoline hydrochloride 0.012%) eye drops, 0.2 FL OZ (6

mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distributed by Medtech

Products Inc., Tarrytown, NY 10591; A Prestige Brands

Company.

Class II

Lot # 16242, Exp 09/19; 16280, Exp 10/19; 17051, Exp 02/20; 17130, Exp

04/20







Medtech Products,

Inc.

Drug Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline

hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Distributed by Select Corporation, Carrolton, TX 75007; Medtech Products Inc., Tarrytown, NY 10591, A

Prestige Brands Company, UPC 6 55708 01039 6.

Class II

Lot #: 16192, 16203, Exp 07/19; 16321, Exp 11/19; 17002, Exp 01/20; 17034, Exp 02/20






Medtech Products,

Inc.



Firm the finished

products. Drug Clear Eyes Redness Relief Hand

Pocket Pal Tray Display; each display (UPC 6 78112 25418 7) contains 48 each of Clear eyes

REDNESS RELIEF (Glycerin 0.25%, Naphazoline

hydrochloride 0.012%) eye drops, 0.2 FL OZ (6 mL) bottle,

Handy Pocket Pal (UPC 6 78112 25418 7); Distributed by Medtech Products Inc., Tarrytown, NY 10591 A

Prestige Brands Company.

Class II

Lot #: 17051, Exp 02/20; 17130, Exp 04/20; 17147, Exp

05/20







Medtech Products,

Inc.

Drug Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx

Only, Manufactured for: Upsher-Smith Laboratories,

LLC, Maple Grove, MN 55369. NDC: 0832-0285-00

Class II

Lot: A2610. exp 3/2020

Failed Dissolution Specifications

Upsher Smith

Laboratories, Inc.

Drug Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.

Class II

Lot #: 1219010961, Exp. 10/24/2019

Lack of Assurance of Sterility.

SCA Pharmaceuti

cals, LLC

Drug Vivitrol (naltrexone for extended-release injectable

suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 mg of Vivitrol, 2) One vial containing 4 mL of diluent, 3)

One 5-mL prepackaged syringe, 4) One 20-gauge 1-inch needle, 5) Two 20-gauge 1.5-inch safety

needles, 6) Two 20-gauge 2-inch safety needles. Rx Only. Manufactured and marketed

by: Alkermes, Inc. Kit NDC: 65757-300-01

Class II

Lot 2018-3010T Exp 8/2021

Labeling: Not Elsewhere

Classified. Drug product kit

recalled due to 1 inch needles being placed in the 1 1/2

inch needle cardboard sleeve

labelled as administration needles. The

product vial is not impacted.

Alkermes Inc



Firm Drug RELPAX (eletriptan HBr) tablets,

40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton,

NDC 0049-2340-45; b) 12-count (2 cards x 6 tablets) per carton,

NDC 0049-2340-05, Rx only, Made in Ireland, Distributed by Pfizer Roerig, Division of Pfizer

Inc., NY, NY 10017.

Class II

Lot #: a) AR5407, Exp 2022 FEB; b)

CD4565, Exp 2022 FEB

Microbial Contamination of

Non-Sterile Products:

contamination with Burkholderia and Pseudomonas

Pfizer Inc.

Drug Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc.,

Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01; NDC

Carton: 0409-3977-03

Class II

Lot #: W20308, Exp. Dec 1, 2019

Lack of Assurance of Sterility

Pfizer Inc.

Drug AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500

Tablets per bottle, NDC 42291-297-50

Class II

Lot #s: 067180011A;

067180012A, Exp. 04/2021;

06718027B1 Exp. 09/2021

Failed Stability Specifications.

AVKARE Inc.

Drug Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx

Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901

Class II

All lots remaining within expiry.

Lack of assurance of sterility.

Pacifico National, Inc. dba

AmEx Pharmacy

Drug Bevacizumab, 1.25 mg/0.05 mL,

31G MJ Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx

Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901

Class II

All lots remaining within expiry.

Lack of assurance of sterility.

Pacifico National, Inc. dba

AmEx Pharmacy

Drug 20% Acetyl-L-Cysteine

Ophthalmic Solutions, dispensed in 3ml dropper

bottle.

Class II

Lots: 07172019@39 exp:

8/31/19, Rx # 215042

06192019@28 exp: 7/03/19, Rx #

219335 06052019@8 exp:

6/19/19; Rx # 222826

Lack of Processing Controls

Compounded Solutions

in Pharmacy



Firm Drug 10% Acetyl-L-Cysteine

Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c)

15 ml, dropper bottles

Class II

Lots: a) 08012019@33

exp: 8/15/19, 07182019@66 exp:

8/01/19, 07182019@15 exp:

8/01/19, 07012019@46 exp.

08/31/19, 07082019@27 exp:

8/31/19, b) 07082019@55

exp: 8/31/19; 07182019@55 exp:

08/31/19; 06242019@55 exp:

8/31/19; 06202019@16 exp:

8/31/19 c) 08052019@11

exp: 11/3/19



in Pharmacy

Drug 5% Acetyl-L-Cysteine Ophthalmic Solutions,

dispensed in a) 5ml , b) 10ml dropper bottles

Class II

Lots a) 07182019@29

exp: 8/31/19, 07082019@2 exp: 8/31/19,

06052019@21 exp:08/31/19 06062019@52 exp: 6/25/19;

b) 07022019@28 exp: 8/31/19



in Pharmacy

Drug Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife

Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99

Class III

05318054B, exp 3/2021

Labeling; Incorrect or Missing Lot

and/or Exp Date; some bottles

labeled with lot number

05318054B instead of

05318034B

Aurobindo Pharma USA

Inc.

Drug Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100

mL Single-use Vial, For

Class III

Lot #s: 091287A, 091377A, Exp.

9/19.

Failed Impurities/Degrad

ation

Akorn, Inc.



Firm Intravenous Use Only, Rx Only, Manufactured by: Akorn, Inc.,

Lake Forest, IL 60045, NDC 17478-903-90.

Specifications: Out of Specification

(OOS) for known impurity, D-

aspartic acid. Drug Eptifibatide Injection, 75

mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For

Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc.,

Lake Forest, IL 60045, NDC 17478-903-90.

Class III

Lot #: 101107A, Exp. 10/19.

Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed

Impurities/Degradation

Specifications: Out of Specification

(OOS) for known impurity, D-

aspartic acid.

Akorn, Inc.

Drug Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-

902-10, b) 200 mg/100 mL (2 mg/mL), 100 mL Single-use Vial,

NDC 17478-902-90, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc.,

Lake Forest, IL 60045.

Class III

Lot #s: a) 091307A,

Exp. 9/19; 101097A,

Exp. 10/19; b) 091277A, Exp. 9/19.

Failed Impurities/Degrad

ation Specifications: Out

of Specification (OOS) for known

impurity, D-aspartic acid.

Akorn, Inc.

Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose

Blisters Carton, NDC 60687-362-21 (Individual Dose NDC: 60687-362-11), Distributed by American Health Packaging,

Columbus, OH

Class III

Lots 186509 and 186982,

exp 6/30/2021

Labeling: Incorrect or Missing

Package Insert; an error in the

Dosage Forms and Strengths section of the insert that incorrectly lists

the tablet description coding

for the tablets.

American Health

Packaging

Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for:

Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made

in India. NDC: 0378-5431-35

Class III

Lot GABH0003, EXP 7/2020

Failed Impurities/ Degradation

Specifications: OOS for unknown

impurity.

Mylan Pharmaceuti

cals Inc.


*Please refer to FDA website for further information at: http://www.fda.gov/Safety/Recalls/default.htm

CURRENT DRUG SHORTAGES

Rocuronium Injection August 21, 2019 Reason for the Shortage

• Athenex has rocuronium available. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi has rocuronium available. • Mylan Institutional refused to provide availability information. • Pfizer has rocuronium on shortage due to manufacturing delays. • Sagent has rocuronium available. • Sandoz has rocuronium available. • X-Gen has rocuronium available.

Estimated Resupply Dates • AuroMedics has rocuronium 10 mg/mL 10 mL vials on intermittent back order and the company is

releasing product as it becomes available. • Pfizer has rocuronium 10 mg/mL 10 mL vials available in limited supply. • Sagent has rocuronium 10 mg/mL 10 mL vials on back order and the company cannot estimate a

release date. • Sandoz has short-dated rocuronium 10 mg/mL 10 mL vials available with an expiration date of

December 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=290 Clotrimazole Lozenges (Clotrimazole Troches) August 21, 2019 Reason for the Shortage

• Hikma did not provide a reason for the shortage. • Perrigo has clotrimazole lozenges on shortage due to increased demand.

Estimated Resupply Dates • Perrigo has clotrimazole 10 mg lozenges in 70 count bottles on intermittent back order and the

company is allocating product as it becomes available. The 10 mg lozenges in 140 count bottles are on back order and the company estimates a release date of mid-September 2019. The 10 mg lozenges in 70 count unit-dose packs are on back order and the company estimates a release date of late-September to early-October 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=541 Bacitracin Ophthalmic Ointment August 21, 2019 Reason for the Shortage

• In early-July 2019, Altaire recalled several lots of certain ophthalmic ointments, including bacitracin ophthalmic ointment. The products were recalled due to a potential for nonsterility. Additional information, including the specific lots affected, is available at https://www.fda.gov/safety/recalls-

http://www.fda.gov/Safety/Recalls/default.htm

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=290



market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-ophthalmic-products.

• Altaire manufactures bacitracin ophthalmic ointment and Perrigo distributes the product. Estimated Resupply Dates

• Perrigo has bacitracin ophthalmic ointment 3.5 gram tubes on back order and the company estimates a release date of late-September to early-October 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=582 Vecuronium Bromide Injection August 22, 2019 Reason for the Shortage

• Pfizer has vecuronium on shortage due to manufacturing delays. • Teva has vecuronium on allocation due to increased demand. • Pfizer sold vecuronium injection to Mylan Institutional in December 2013. • Mylan Institutional refuses to provide availability information. • Ben Venue has stopped production in its plant in Bedford, Ohio and closed in 2014. • Sun Pharma has vecuronium available. • Sagent is not marketing vecuronium 10 mg and 20 mg vials. • Fresenius Kabi has vecuronium available.

Estimated Resupply Dates • Pfizer has vecuronium 10 mg and 20 mg vials on back order and the company estimates a release

date of October 2019 for the 10 mg vials and November 2019 for the 20 mg vials. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=167 Trifluoperazine Tablets August 22, 2019 Reason for the Shortage

• Mylan refuses to provide availability information. • Sandoz has trifluoperazine available. • Upsher-Smith has trifluoperazine available.

Estimated Resupply Dates • Upsher-Smith and Sandoz have trifluoperazine tablets available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=457 Sodium Polystyrene Sulfonate Powder August 22, 2019 Reason for the Shortage

• CMP Pharma has sodium polystyrene sulfonate on back order due to a raw material shortage. They are using available powder to make suspension.

• ECI Pharmaceuticals has sodium polystyrene sulfonate powder available. • KVK-Tech has sodium polystyrene sulfonate powder available. • Marlex has sodium polystyrene sulfonate powder available. • Sunrise Pharmaceuticals has sodium polystyrene sulfonate powder available. • Trigen did not provide a reason for the shortage.





Estimated Resupply Dates • CMP Pharma has sodium polystyrene sulfonate in 454 gram bottles on back order and the company

cannot estimate a release date. • Trigen has sodium polystyrene sulfonate in 454 gram bottles on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=523 Sodium Polystyrene Sulfonate Oral or Rectal Suspension August 22, 2019 Reason for the Shortage

• CMP Pharma reports that increased demand has led to a shortage of raw material required to manufacture the products. They are using available powder to manufacture the suspension.

• Perrigo has temporarily discontinued their Kionex suspension and sodium polystyrene sulfonate (sorbitol-free) suspension. They cannot estimate when these products will be manufactured again.

• Hikma is not currently marketing sodium polystyrene sulfonate suspension. Estimated Resupply Dates

• CMP Pharma has SPS Suspension on allocation and the company is shipping supplies regularly. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=430 Pentamidine Isethionate August 22, 2019 Reason for the Shortage

• Fresenius Kabi had Nebupent and Pentam 300 on back order due to a short-term manufacturer delay.

• Seton Pharmaceuticals has pentamidine isethionate injection on shortage due to high demand. Estimated Resupply Dates

• Seton Pharmaceuticals has pentamidine isethionate 300 mg vials for injection on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=584 Cyclosporine Capsules August 22, 2019 Reason for the Shortage

• Apotex has cyclosporine capsules available. • Sandoz has discontinued cyclosporine (modified) capsules. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Teva has cyclosporine (modified) 50 mg capsules on back order and the company estimates a release

date of late-August 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=476 Lorazepam Tablets August 23, 2019 Reason for the Shortage

• Aurobindo refuses to provide availability information. • Leading has all lorazepam tablet presentations on intermittent back order due to increased demand. • Major did not provide a reason for the shortage.






• Mylan has discontinued all bottled presentations. • Mylan Institutional discontinued all unit-dose blister pack presentations. • Sandoz discontinued all lorazepam presentations. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Major has lorazepam 0.5 mg and 1 mg tablets in 100 count bottles on back order and the company

estimates a release date of late-July 2019. The 1 mg tablets in 100 count unit-dose packages are on back order and the company estimates a release date of mid-August 2019.

• Leading has all lorazepam tablet presentations on intermittent back order and they are releasing product as it becomes available.

• Teva has lorazepam 0.5 mg tablets in 500 and 1,000 count, 1 mg tablets in 100 and 1,000 count, and 2 mg tablets in 1,000 count bottles on back order, and the company estimates release dates of late-August 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=480 Amino Acid Products August 23, 2019 Reason for the Shortage

• Baxter discontinued Premasol 6% in late-2018. • BBraun did not provide a reason for the shortage. • ICU Medical has Aminosyn presentations available. ICU Medical discontinued several Aminosyn

products in September 2018. Estimated Resupply Dates

• BBraun has Trophamine 10% 500 mL and HepatAmine 8% 500 mL in glass containers on intermittent back order and the company is releasing supplies as they become available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=564 Thiamine Injection August 24, 2019 Reason for the Shortage

• Fresenius Kabi has thiamine injection on shortage due to short manufacturing delay. • Mylan Institutional refuses to provide availability information.

Estimated Resupply Dates • Fresenius Kabi has thiamine 100 mg/mL 2 mL vials available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=502 Potassium Phosphate Injection August 24, 2019 Reason for the Shortage

• American Regent has not had potassium phosphate injection available since 2012. It is unclear if and when product will return to market.

• Fresenius Kabi had potassium phosphate injection on shortage due to increased demand. • Pfizer had potassium phosphate injection on shortage due to manufacturing delays.

Estimated Resupply Dates • All marketed presentations are available.





https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=305 Morphine Sulfate Immediate-Release Tablets August 24, 2019 Reason for the Shortage

• Hikma did not provide a reason for the shortage. Estimated Resupply Dates

• Hikma has all morphine immediate-release tablets available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=504 Mepivacaine Injection August 24, 2019 Reason for the Shortage

• Fresenius Kabi has Polocaine available. • Pfizer states the reason for the shortage is manufacturing delays.

Estimated Resupply Dates • Pfizer has 2% Carbocaine 20 mL preservative-free vials, 2% Carbocaine 50 mL multiple-dose vials, 1%

Carbocaine 30 mL preservative-free vials, and 1.5% Carbocaine 30 mL preservative-free vials on back order and the company estimates a release date of March 2020. The 1% Carbocaine 50 mL multiple-dose vials are on back order and the company estimates a release date of November 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=331 Letermovir Injection August 24, 2019 Reason for the Shortage

• Merck has Prevymis on shortage due to a supply disruption. Estimated Resupply Dates

• Merck has Prevymis 20 mg/mL 12 mL vials on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=487 Physostigmine Salicylate Injection August 26, 2019 Reason for the Shortage

• Akorn did not provide a reason for the shortage. They are the sole suppliers of physostigmine salicylate injection.

Estimated Resupply Dates • Akorn has physostigmine salicylate 1 mg/mL 2 mL ampules on back order and the company

estimates a release date of late-September 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=532 Immune Globulin, Intravenous or Subcutaneous (Human) August 26, 2019 Reason for the Shortage

• CSL Behring has Hizentra and Privigen on shortage due to increased demand.







• Grifols has Gamunex-C and Flebogamma on shortage due to increased demand. • Kedrion Biopharma has Gammaked available to current customers. • Octapharma has Octagam on shortage due to increased demand. • Takeda has HyQvia, Cuvitru, and Gammagard on shortage due to increased demand.

Estimated Resupply Dates • ADMA Biologics received approval on April 1, 2019 for Asceniv (immune globulin intravenous, human

- slra) 10% liquid. The company estimates a launch date of 4th quarter 2019. The company also recently launched Bivigam intravenous immune globulin. The product will be available through BioCare SD.

• CSL Behring is releasing Hizentra and Privigen regularly and wholesalers are allocating product. • Grifols has all Gamunex-C and Flebogamma presentations on intermittent back order and the

company is releasing product as it becomes available. • Grifols received approval on July 3, 2019 for Xembify (immune globulin subcutaneous, human - klhw)

20% solution. The company cannot estimate a launch date. • Octapharma has all Octagam presentations on allocation. • Takeda has Cuvitru and HyQvia on allocation and the company is reviewing all orders. • Takeda has all Gammagard Liquid presentations on intermittent back order and the company is

allocating product as it becomes available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=527 Erythromycin Lactobionate Injection August 26, 2019 Reason for the Shortage

• Pfizer had Erythrocin on shortage due to manufacturing delays. Estimated Resupply Dates

• Pfizer has Erythrocin 500 mg ADD-Vantage vials and 500 mg regular vials available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=247 Progesterone Injection August 27, 2019 Reason for the Shortage

• American Regent is not currently marketing progesterone injection. • AuroMedics has progesterone injection available. • Fresenius Kabi had progesterone on shortage due to increased demand and manufacturing delays. • Hikma did not provide a reason for the shortage. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • All marketed presentations are available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=381 Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution August 27, 2019 Reason for the Shortage

• Altaire has recalled several medications due concerns over lack of sterility assurance. More information can be found at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-




alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-ophthalmic-products-sold-ocusoft.

Estimated Resupply Dates • Altaire has fluorescein/proparacaine 5 mL bottles on back order and the company cannot estimate a

release date. • OCuSOFT has Flucaine 5 mL bottles on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=581 Diphenhydramine Injection August 27, 2019 Reason for the Shortage

• Fresenius Kabi has diphenhydramine injection available. • Hikma did not provide a reason for the shortage. • Mylan refuses to provide availability information. • Pfizer has diphenhydramine injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Pfizer has diphenhydramine 50 mg/mL 1 mL vials on back order and the company estimates a release

date of August 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=456 Diphenhydramine Injection August 27, 2019 Reason for the Shortage

• Fresenius Kabi has diphenhydramine injection available. • Hikma did not provide a reason for the shortage. • Mylan refuses to provide availability information. • Pfizer has diphenhydramine injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Pfizer has diphenhydramine 50 mg/mL 1 mL vials on back order and the company estimates a release

date of August 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=456 Nicardipine Hydrochloride Injection August 28, 2019 Reason for the Shortage

• Hikma has nicardipine vials available. • Mylan refuses to provide availability information. • Chiesi did not provide a reason for the shortage. • Chiesi discontinued Cardene 40 mg/200 mL in 5% dextrose premixed bags in mid-2019.

Estimated Resupply Dates • Chiesi has all Cardene IV premixed bags on allocation.







Mycophenolate Mofetil Capsules and Tablets August 28, 2019 Reason for the Shortage

• Accord did not provide a reason for the shortage. • Ascend did not provide a reason for the shortage. • Hikma did not provide a reason for the shortage. • Mylan refuses to provide updated availability information. • Genentech has Cellcept available. • Sandoz did not provide a reason for the shortage.

Estimated Resupply Dates • Accord has all mycophenolate mofetil presentations on allocation. • Ascend has all mycophenolate mofetil presentations on intermittent back order and the company is

releasing product as it becomes available. • Hikma has mycophenolate mofetil 250 mg capsules in 100 count and 500 count and 500 mg tablets

in 100 count and 500 count on allocation. • Sandoz has mycophenolate mofetil 250 mg capsules in 1,440 count are on back order and the

company cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=448 Hepatitis B Vaccine (Recombinant) August 28, 2019 Reason for the Shortage

• Merck has Recombivax HB on shortage due to increase in global demand. • GlaxoSmithKline has Engerix B products available. • GlaxoSmithKline discontinued Engerix B pediatric vials in October 2017.

Estimated Resupply Dates • Merck has Recombivax HB adult formulation vials and syringes on back order and the company

estimates this will continue through 2019. • Merck has Recombivax HB pediatric/adolescent formulation syringes and pediatric/adolescent

formulation vials in limited supply and this will continue through 2019. Merck's limited supply is being allocated to the CDC to ensure use is in accordance with their clinical guidance.

• Merck has Recombivax HB dialysis formulation 40 mcg/mL on back order and the company estimates this will continue through 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=320 Heparin Sodium Premixed Bags August 28, 2019 Reason for the Shortage

• Baxter has heparin premix available. • BBraun has heparin premixes available. • Fresenius Kabi has put heparin on a protective allocation due to a potential shortage of raw

ingredient. The letter describing this in detail is available at the following link:




https://www.fresenius-kabi.com/us/news/fresenius-kabi-responds-to-a-potential-shortage-of-heparin.

• Pfizer has heparin on shortage due to manufacturing delays. Estimated Resupply Dates

• Pfizer has heparin 25,000 units/250 mL in 0.45% sodium chloride premixed bags available in limited supply. Heparin 1,000 units/500 mL 0.9% sodium chloride premixed bags are available in limited supply.

• BBraun has all heparin premixed bags on intermittent back order and the company is releasing product as it becomes available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=468 Guanfacine Hydrochloride Tablets August 28, 2019 Reason for the Shortage

• Amneal has guanfacine tablets available. • Mylan refuses to provide updated availability information. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Teva has guanfacine 1 mg and 2 mg tablets in 100 count bottles on back order and the company

cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=508 Fluvastatin Capsules August 28, 2019 Reason for the Shortage

• Mylan refuses to provide updated availability information. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Teva has fluvastatin 20 mg and 40 mg capsules in 100 count on back order and the company

estimates a release date of mid-September 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=561 Bisacodyl Suppositories August 28, 2019 Reason for the Shortage

• G&W Laboratories discontinued bisacodyl suppositories. • Major has bisacodyl suppositories on shortage due to increased demand. • Perrigo has bisacodyl suppositories on shortage due to increased demand. • Rugby Laboratories has bisacodyl suppositories on shortage due to increased demand.

Estimated Resupply Dates • Major has bisacodyl 10 mg suppositories in 12 count and 100 count on back order and the company

cannot estimate a release date. • Perrigo has bisacodyl 10 mg suppositories in 50 count on allocation. • Rugby Laboratories has bisacodyl 10 mg suppositories in 100 count on back order and the company

cannot estimate a release date.

https://www.fresenius-kabi.com/us/news/fresenius-kabi-responds-to-a-potential-shortage-of-heparin

https://www.fresenius-kabi.com/us/news/fresenius-kabi-responds-to-a-potential-shortage-of-heparin





https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=565 Amyl Nitrite Inhalation August 28, 2019 Reason for the Shortage

• James Alexander has amyl nitrite inhalation on shortage because they are in the process of serializing the product.

Estimated Resupply Dates • James Alexander has amyl nitrite inhalation on back order and the company estimates a release date

in mid- to late-September 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=505 Cefotaxime Sodium Injection August 29, 2019 Reason for the Shortage

• Hospira has discontinued Claforan. Sanofi-Aventis manufactured Claforan for Hospira and is no longer making the product.

• Baxter discontinued Claforan in late-2015. • Hikma is not currently marketing cefotaxime injection.

Estimated Resupply Dates • Apollo Pharmaceuticals is temporarily importing cefotaxime 1 gram and 2 gram vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=51 Argatroban Injection August 29, 2019 Reason for the Shortage

• AuroMedics did not provide a reason for the shortage. • Chiesi did not provide a reason for the shortage. • Fresenius Kabi has argatroban available. • Hikma did not provide a reason for the shortage. • Mylan Institutional refuses to provide availability information. • Par has argatroban available. • Pfizer has argatroban on shortage due to manufacturing delay. • Sandoz discontinued argatroban 1 mg/mL 50 mL vials in April 2019. • Teva has argatroban temporarily unavailable.

Estimated Resupply Dates • AuroMedics has argatroban 1 mg/mL 50 mL vials on intermittent back order. • Chiesi has argatroban 1 mg/mL 50 mL vials on back order and the company cannot estimate a

release date. • Pfizer has argatroban 100 mg/mL 2.5 mL vials available in limited supply.







Tacrolimus Injection August 30, 2019 Reason for the Shortage

• Astellas has Prograf injection on allocation due to a shortage of raw materials. Estimated Resupply Dates

• Astellas has Prograf 5 mg/mL 1 mL ampules on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=588 Albuterol Inhalation Solution August 30, 2019 Reason for the Shortage

• Akorn did not provide a reason for the shortage. Estimated Resupply Dates

• Akorn has albuterol sulfate 0.5% solution on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=470 Sufentanil Injection September 03, 2019 Reason for the Shortage

• Akorn had Sufenta injection on shortage due to increased demand for the product. • Hikma stopped marketing sufentanil injection in October 2018. • Pfizer has sufentanil injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Pfizer has sufentanil 0.5 mg/mL 1 mL, 2 mL, and 5 mL vials on back order and the company estimates

a release date of September 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=376 Potassium Iodide and Iodine (Lugol's Solution or Strong Iodine Solution) 14 mL bottles September 03, 2019 Reason for the Shortage

• Safecor did not provide a reason for the shortage. • The 16 ounce bottle presentations are not affected.

Estimated Resupply Dates • Safecor has Lugol's Solution/Strong Iodine Solution on back order and the company estimates a

release date in early-September 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=589 Potassium Acetate Injection September 03, 2019 Reason for the Shortage

• American Regent has not had product available for several years. It is unclear if they will market potassium acetate again in the future.

• Pfizer has potassium acetate on shortage due to manufacturing delays. Estimated Resupply Dates






• Pfizer has potassium acetate 2 mEq/mL 20 mL vials on back order and the company estimates a release date of September 2019. The 50 mL vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=344 Octreotide Injection September 03, 2019 Reason for the Shortage

• Fresenius Kabi had octreotide injection on back order due to increased demand. • Hikma has octreotide injection available. • Mylan Institutional refuses to provide availability updates. • Sagent has octreotide on shortage due to increased demand. • Sun Pharma is not currently marketing octreotide. • Teva did not provide a reason for the shortage. • Novartis has Sandostatin available. The 200 mcg/mL 5 mL vials were discontinued in early-2018.

Estimated Resupply Dates • Sagent has octreotide 50 mcg/mL 1 mL vials and 100 mcg/mL 1 mL vials on back order and the

company estimates a release date in November 2019. The 200 mcg/mL 5 mL vials, 500 mcg/mL 1 mL vials, and 1,000 mcg/mL 5 mL vials are on back order and the company estimates a release date of September 2019. There are short-dated 1,000 mcg/mL 5 mL vials available with an expiration date of February 2020.

• Teva has short-dated 500 mcg/mL 1 mL vials available with an expiration date of October 2019. The 100 mcg/mL 1 mL vials are on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=229 Mannitol Injection September 03, 2019 Reason for the Shortage

• American Regent is not currently marketing mannitol. • Baxter did not provide a reason for the mannitol shortage. • BBraun has mannitol 500 mL premixed bags available. The 250 mL premixed bags were discontinued. • Fresenius Kabi had mannitol on shortage due to increased demand. • ICU Medical has mannitol on shortage due to manufacturing delays. • Pfizer has mannitol on shortage due to manufacturing delays.

Estimated Resupply Dates • Pfizer has mannitol 250 mg/mL 50 mL vials available in limited supply. • ICU Medical has mannitol 200 mg/mL 250 mL premixed bags on back order and the company

estimates a release date of late-September 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=341 Ketorolac Injection September 03, 2019 Reason for the Shortage

• Alvogen did not provide a reason for the shortage.





• Amphastar did not provide a reason for the shortage. • Athenex has ketorolac available. • BD RX is now part of Fresenius Kabi. • Fresenius Kabi has most ketorolac presentations available. • Fosun Pharma has ketorolac available. • Pfizer has ketorolac injection on back order due to manufacturing delays. • Sagent states the reason for the shortage is manufacturing delay. • Hikma did not provide a reason for the shortage. • Ben Venue closed its plant in Bedford, Ohio in July 2014. • Virtus discontinued ketorolac in March 2019. • FDA imposed an import ban in mid-2013 on several Wockhardt products including ketorolac. • Sprix Nasal Spray is not affected by this shortage.

Estimated Resupply Dates • Alvogen has ketorolac 30 mg/mL 1 mL vials and 2 mL vials on back order and the company cannot

estimate a release date.1 • Amphastar has ketorolac 30 mg/mL 1 mL vials on back order and the company cannot estimate a

release date. • Fresenius Kabi has ketorolac 15 mg/mL 1 mL prefilled syringes on back order and the company

estimates a release date of 4th quarter 2019. The 30 mg/mL 1 mL vials are on back order and the company estimates a release date of early-September 2019. The ketorolac 30 mg/mL 1 mL prefilled syringes are available with short expiry of < 6 months.

• Hikma has all ketorolac presentations on back order and the company estimates a release date of mid- to late-January 2020.

• Pfizer has ketorolac 15 mg/mL 1 mL vials available in limited supply. The 30 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of March 2020. The 30 mg/mL 2 mL Carpuject syringes for intramuscular injection and 30 mg/mL 1 mL iSecure syringes are on back order and the company estimates a release date of August 2020. The ketorolac 30 mg/mL 1 mL vials are on back order and the company estimates a release date of September 2019.

• Sagent has ketorolac 15 mg/mL 1 mL vials, 30 mg/mL 1 mL vials, and 30 mg/mL 2 mL vials for intramuscular injection on back order and the company estimates a release date of October 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=113 Heparin Injection September 03, 2019 Reason for the Shortage

• Fresenius Kabi has put heparin on a protective allocation due to a potential shortage of raw ingredient. The letter describing this in detail is available at the following link: https://www.fresenius-kabi.com/us/news/fresenius-kabi-responds-to-a-potential-shortage-of-heparin.

• Hikma did not provide a reason for the shortage. • Mylan refuses to provide updated availability information. • Pfizer has heparin on shortage due to manufacturing delays. • Sagent has heparin on shortage due to manufacturing issues and increased demand.



Estimated Resupply Dates • Fresenius Kabi has heparin 5,000 unit/mL 10 mL vials on back order and the company estimates a

release date of early-September 2019. The 10,000 unit/mL 4 mL vials are on back order and the company cannot estimate a release date. All other presentations are on allocation.

• Hikma has 1,000 unit/mL 2 mL vials, 5,000 unit/mL 2 mL vials, and 10,000 unit/mL 2 mL vials on allocation.

• Pfizer has 5,000 unit/mL 1 mL Carpuject syringes available in limited supply. The 5,000 unit/mL 1 mL glass vials are on back order and the company estimates a release date of December 2019. The 5,000 unit/mL 10 mL vials are on back order and the company estimates a release date of November 2019. The 1,000 unit/mL 10 mL glass vials are on back order and the company estimates a release date of October 2019. The 1,000 unit/mL 30 mL vials are on back order and the company estimates a release date of September 2019. The 10,000 unit/mL 0.5 mL Carpuject syringes are available in limited supply. The 1,000 unit/mL 10 mL vials (NDC 00069-0058-01) are on back order and the company estimates a release date of October 2019.

• Sagent has all presentations on back order and the company estimates a release date in September 2019. There are short-dated 20,000 unit/mL 1 mL vials available with an expiration date of January 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=353 Fentanyl Citrate Injection September 03, 2019 Reason for the Shortage

• Akorn has fentanyl injection available. They are not currently marketing 25 count fentanyl ampules. • Hikma has fentanyl injection on shortage due to supply and demand issues. They are not currently

marketing fentanyl ampules, just vials. • Pfizer has fentanyl injection on shortage due to manufacturing delays. The 20 mL ampules were

discontinued in September 2017. • Fresenius Kabi has fentanyl injection available.

Estimated Resupply Dates • Hikma has fentanyl 50 mcg/mL 20 mL vials on back order and the company estimates a release date

of mid-September 2019. • Pfizer has fentanyl 50 mcg/mL 2 mL, 20 mL, and 50 mL vials on back order and the company

estimates a release date of September 2019 for the 2 mL and 50 mL vials and November 2019 for the 20 mL vials. The 2 mL Carpuject syringes are on back order and the company estimates a release date of August 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=315 Dobutamine Injection September 03, 2019 Reason for the Shortage

• Baxter has dobutamine available. • Pfizer has dobutamine on shortage due to manufacturing delays.

Estimated Resupply Dates




• Pfizer has dobutamine 12.5 mg/mL 20 mL and 40 mL latex-free vials on back order with an estimated release date of March 2020 for the 20 mL vials and December 2019 for the 40 mL vials.

• Pfizer has dobutamine 4 mg/mL in 250 mL bags on back order and the company estimates a release date of September 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=296 Diltiazem Hydrochloride Injection September 03, 2019 Reason for the Shortage

• Diltiazem Hydrochloride injection, Hikma, 5 mg/mL, 25 mL vial, 10 count, NDC 00641-6015-10 • Diltiazem Hydrochloride injection, Pfizer, 5 mg/mL, 10 mL vial, 10 count, NDC 00409-1171-02 • Diltiazem Hydrochloride injection, Pfizer, 5 mg/mL, 5 mL vial, 10 count, NDC 00409-1171-01 • Diltiazem Hydrochloride lyophilized powder for solution for injection, Pfizer, 100 mg, ADD-Vantage

vial, 10 count, NDC 00409-4350-03 Estimated Resupply Dates

• Hikma has diltiazem 5 mg/mL 25 mL vials on allocation. • Pfizer has 100 mg ADD-Vantage vials available in limited supply. The 5 mg/mL 5 mL and 10 mL vials

are also on back order and the company estimates a release date of March 2020 for the 5 mL vials and September 2019 for the 10 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=26 Diclofenac Potassium Tablets September 03, 2019 Reason for the Shortage

• Mylan refuses to provide availability information. • Teva did not provide a reason for the shortage. • Sandoz discontinued diclofenac potassium tablets.

Estimated Resupply Dates • Teva has diclofenac potassium 50 mg tablets in 100 count and 500 count on back order and the

company estimates a release date of late-September 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=537 Clindamycin Phosphate Injection September 03, 2019 Reason for the Shortage

• Alvogen did not provide a reason for the shortage. • Akorn did not provide a reason for the shortage. • Baxter has clindamycin injection available. • Fresenius Kabi did not provide a reason for the shortage. • Pfizer did not provide a reason for the shortages. Pfizer discontinued Cleocin premixed bags in 2018. • Sagent did not provide a reason for the shortage. • Sandoz did not provide a reason for the shortage.






• Akorn has clindamycin 600 mg/50 mL and 900 mg/50 mL in dextrose premixes on back order and the company cannot estimate a release date.

• Alvogen has clindamycin 150 mg/mL 2 mL, 4 mL, and 6 mL ADD-Vantage vials on long term back order and the company cannot estimate a release date. Clindamycin 150 mg/mL 2 mL, 4 mL, and 6 mL vials are short-dated with expiration dates of May 2020 for the 2 mL vials, April 2020 for the 4 mL vials, and February 2020 for the 6 mL vials. Clindamycin 150 mg/mL 60 mL vials are on back order and the company cannot estimate a release date.

• Fresenius Kabi has short-dated clindamycin 150 mg/mL 2 mL, 4 mL, 6 mL, and 60 mL vials available with an expiration date of <3 months for the 2 mL vials, <5 months for the 4 mL vials, <2 months for the 6 mL vials, and <5 months for the 60 mL vials.

• Pfizer has Cleocin 150 mg/mL 2 mL, 4 mL, and 6 mL ADD-Vantage vials on back order and the company estimates a release date of June 2020.

• Sagent has short-dated clindamycin 150 mg/mL 2 mL vials with an expiration date of November 2019. The 150 mg/mL 4 mL vials are short-dated with an expiration date of February 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=97 Cefoxitin Sodium Injection September 03, 2019 Reason for the Shortage

• Apotex has temporarily discontinued cefoxitin vials. • BBraun has cefoxitin on allocation due to increased demand. • Fresenius Kabi did not provide a reason for the shortage. • Hikma did not provide a reason for the shortage. Hikma is not currently marketing cefoxitin 10 gram

vials. • Sagent has cefoxitin on shortage due to increased demand and manufacturing delay. • WG Critical Care did not provide a reason for the shortage.

Estimated Resupply Dates • Apotex has temporarily discontinued cefoxitin 1 gram, 2 gram, and 10 gram vials and the company

cannot estimate when product will be available again. • BBraun has cefoxitin 1 gram and 2 gram DUPLEX bags on back order and the company cannot

estimate a next release date. • Fresenius Kabi has cefoxitin 1 gram and 2 gram vials on back order and the company estimates a

release date of mid-September 2019. • Hikma has cefoxitin 1 gram vials on back order and the company estimates a release date in late-

October 2019. The 2 gram vials are on allocation. The 10 gram vials are on back order and the company estimates a release date of January 2020.

• Sagent has cefoxitin 1 gram vials on allocation. The 2 gram and 10 gram vials are on back order and the company estimates a release date of September 2019.

• WG Critical Care has cefoxitin 1 gram and 2 gram vials on back order and the company estimates a release date of mid- to late-September 2019.





Calcium Chloride Injection September 03, 2019 Reason for the Shortage

• American Regent did not provide a reason for the shortage. • Amphastar has calcium chloride on shortage due to increased demand. • Pfizer has calcium chloride on shortage due to manufacturing delays. • Mylan Institutional has withdrawn calcium chloride syringes from the market. The company recalled

the syringes in April 2015 due to incompatibility of the syringes and some needless adaptors. Estimated Resupply Dates

• American Regent has calcium chloride 100 mg/mL 10 mL vials available in limited supply. • Amphastar has calcium chloride 100 mg/mL 10 mL syringes on allocation. • Pfizer has calcium chloride 100 mg/mL 10 mL Ansyr syringes on back order and the company

estimates a release date of December 2019. The 100 mg/mL 10 mL LifeShield syringes are on back order and the company estimates a release date of September 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=48 50% Dextrose Injection September 03, 2019 Reason for the Shortage

• Amphastar has 50% dextrose injection on allocation due to increased demand. • Pfizer has 50% dextrose injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Pfizer has 50% dextrose 50 mL LifeShield syringes on back order and the company estimates a

release date of October 2019. The 50% dextrose 50 mL Ansyr syringes are on back order and the company estimates a release date of December 2019. The 50% dextrose 50 mL vials are on back order and the company estimates a release date of September 2019.

• Amphastar has 50% dextrose 50 mL Luer-Jet syringes on allocation with regular releases. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=306 Vancomycin Hydrochloride Injection September 04, 2019 Reason for the Shortage

• Alvogen has vancomycin injection available. • Athenex has vancomycin injection available. • AuroMedics did not provide a reason for the shortage. • Pfizer has vancomycin vials on back order due to manufacturing delays. • Fresenius Kabi has vancomycin injection available. • Mylan Institutional refuses to provide availability information. • Baxter has vancomycin injection available. • Samson Medical Technologies has vancomycin injection available. • Sagent has vancomycin injection available. • Xellia Pharmaceuticals has vancomycin injection and vancomycin premixed bags available.





• AuroMedics has vancomycin 1 gram vials on long-term back order and the company cannot estimate a release date.

• Pfizer has 5 gram vials available in limited supply. There are short-dated 500 mg ADD-Vantage vials available with an expiration date of October 2019. The 750 mg ADD-Vantage vials are on back order and the company estimates a release date of March 2020. The 1 gram ADD-Vantage vials are on back order and the company estimates a release date of September 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=25 Protamine Sulfate Injection September 04, 2019 Reason for the Shortage

• Fresenius Kabi has protamine on shortage due to increased demand. Estimated Resupply Dates

• Fresenius Kabi has protamine 10 mg/mL 5 mL and 25 mL vials available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=586 Magnesium Sulfate Injection September 04, 2019 Reason for the Shortage

• American Regent is not currently marketing magnesium sulfate which has been unavailable since late 2012.

• Fresenius Kabi had magnesium sulfate injection on shortage due to increased demand for the product.

• Pfizer has magnesium sulfate injection on shortage due to manufacturing delays. • X-Gen discontinued magnesium sulfate in April 2018. • Exela launched magnesium sulfate vials in May 2018. • WG Critical Care had magnesium sulfate injection on shortage due to increased demand for the

product. Estimated Resupply Dates

• Pfizer has magnesium sulfate 500 mg/mL 20 mL vials on back order and the company estimates a release date of March 2020. The 500 mg/mL 10 mL syringes are on back order and the company estimates a release date of March 2020. The 40 mg/mL 500 mL premixed bags are on back order and the company estimates a release date of September 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=21 Hydralazine injection September 04, 2019 Reason for the Shortage

• Akorn had product on back order due to increased demand. • American Regent is not currently marketing hydralazine injection. • Fresenius Kabi did not provide a reason for the shortage. • X-Gen did not provide a reason for the shortage.






• X-Gen has hydralazine 20 mg/mL 1 mL vials on back order and the company estimates a release date of late-September 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=431 Dexrazoxane Injection September 04, 2019 Reason for the Shortage

• Cumberland Pharmaceuticals relaunched Totect in late-July 2017. • Fosun Pharma has dexrazoxane available. • Hikma did not provide a reason for the shortage. • Mylan Institutional refuses to provide availability information. • Pfizer states manufacturing delay as the reason for the shortage.

Estimated Resupply Dates • Pfizer has Zinecard 500 mg vials on back order and the company estimates a release date of

December 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=107 Tacrolimus Capsules September 5, 2019 Reason for the Shortage

• Accord has tacrolimus on allocation due to raw ingredient shortage. • Astellas has Prograf on allocation. • Bionpharma did not provide a reason for the shortage. • Lannett has discontinued tacrolimus capsules. • Major did not provide a reason for the shortage. • Mylan refuses to provide availability information. • Sandoz has tacrolimus available. • The extended-release products such as Astragraf XL capsules and Envarsus XR tablets are not

affected by this shortage. Estimated Resupply Dates

• Accord has tacrolimus 0.5 mg, 1 mg, and 5 mg capsules on allocation. • Astellas has Prograf capsules on allocation. • Bionpharma has tacrolimus 0.5 mg, 1 mg, and 5 mg capsules on back order and the company cannot

estimate a release date. • Major has tacrolimus 0.5 mg and 5 mg capsules on back order and the company estimates a release

date of late-September 2019. The 1 mg capsules are on back order and the company cannot estimate a release date.

• Sandoz has tacrolimus 5 mg capsules on back order and the company cannot estimate a release date. • Strides has tacrolimus 1 mg capsules on allocation.





Ondansetron Hydrochloride Injection September 5, 2019 Reason for the Shortage

• Apotex has ondansetron injection available. • Athenex had ondansetron injection on shortage due to increased demand. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi has ondansetron injection available. • Heritage had ondansetron on shortage due to increased demand. Heritage discontinued

ondansetron 2 mg/mL 2 mL vials in 10 count in late-2018. • Hikma did not provide a reason for the shortage. • Mylan Institutional refuses to provide availability information. • Pfizer has ondansetron injection on shortage due to manufacturing delays. • Sagent has ondansetron injection on shortage due to increased demand and manufacturing delays. • Novartis discontinued Zofran 20 mL vials in May 2018.

Estimated Resupply Dates • AuroMedics has ondansetron 2 mg/mL 2 mL vials and 20 mL vials on intermittent back order and the

company is releasing supplies as they become available. • Fresenius Kabi has ondansetron 2 mg/mL 20 mL vials on back order and the company cannot

estimate a release date. • Hikma has ondansetron 2 mg/mL 20 mL vials in 1 count and 10 count on back order and the

company cannot estimate a release date. • Pfizer has ondansetron 2 mg/mL 2 mL iSecure syringes on back order and the company estimates a

release date of August 2020. The 2 mg/mL 20 mL vials are on back order and the company estimates a release date of September 2019.

• Sagent has ondansetron 2 mg/mL 2 mL vials and 20 mL vials on back order and the company estimates a release date of October 2019 for the 2 mL vials and September 2019 for the 20 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=405 Fluticasone and Salmeterol Powder for Inhalation September 5, 2019 Reason for the Shortage

• Teva Respiratory did not provide a reason for the shortage. • Other fluticasone and salmeterol dry powder inhalers are not affected by the shortage.

Estimated Resupply dates • Teva Respiratory has AirDuo Respiclick available. • Teva Respiratory has fluticasone 113 mcg/salmeterol 14 mcg and fluticasone 232 mcg/salmeterol 14

mcg on back order and the company estimates a release date of mid-September 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=544 Doxorubicin Injection September 5, 2019 Reason for the Shortage

• Hikma did not provide a reason for the shortage of Adriamycin.[1] • Teva had doxorubicin solution for injection on shortage due to increased demand. They discontinued

doxorubicin presentations with NDCs starting in 00703 in early-January 2019.[2-3] • Fresenius Kabi did not provide a reason for the shortage.[4] • Caraco has discontinued doxorubicin solution for injection 25 mL and 100 mL vials.[5]


• Pfizer has doxorubicin on shortage due to manufacturing delays.[6] • Sagent has doxorubicin available.[7] • Mylan Institutional discontinued doxorubicin 10 mg lyophilized powder for injection in early 2019.[8] • Athenex has doxorubicin available.[9]

Estimated Resupply Dates • Pfizer has short-dated doxorubicin 2 mg/mL 100 mL vials available in limited supply. Doxorubicin 2

mg/mL 75 mL vials are on back order and the company estimates a release date in September 2019. • Teva has doxorubicin 2 mg/mL 25 mL vials on back order and the company cannot estimate a release

date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=108 Cyclosporine Injection September 5, 2019 Reason for the Shortage

• Novartis has Sandimmune available. • Perrigo did not provide a reason for the shortage

Estimated Resupply Dates • Perrigo has cyclosporine 50 mg/mL 5 mL ampules on back order and the company cannot estimate a

release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=534 Calcitriol Injection September 5, 2019 Reason for the Shortage

• Akorn did not provide a reason for the shortage. Estimated Resupply Dates

• Akorn has calcitriol 1 mcg/mL 1 mL ampules on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=464 Aspirin Suppositories September 5, 2019 Reason for the Shortage

• Perrigo has aspirin suppositories on shortage due to manufacturing delays Estimated Resupply Dates

• Perrigo has aspirin 300 mg and 600 mg suppositories on back order and the company estimates a release date of late-September 2019 for the 300 mg suppositories and early-October 2019 for the 600 mg suppositories

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=568 Ampicillin Sodium and Sulbactam Sodium Injection September 5, 2019 Reason for the Shortage

• AuroMedics has ampicillin sulbactam vials on back order due to increased demand and manufacturing delays.

• Fresenius Kabi is not currently marketing ampicillin sulbactam injection. • Meitheal Pharmaceuticals did not provide a reason for the shortage.


• Mylan Institutional refuses to provide availability information • Pfizer has discontinued generic ampicillin sulbactam except for the 1.5 gram and 3 gram ADD-

Vantage vials. • Sagent has ampicillin sulbactam vials on back order due to manufacturing delays and increased

demand. • Sandoz discontinued ampicillin sulbactam. • WG Critical Care states the shortage is due to increased demand.

Estimated Resupply Dates • AuroMedics has ampicillin sulbactam 3 gram and 15 gram vials on intermittent back order and the

company is releasing product as it becomes available. The 1.5 gram vials are on long-term back order and the company cannot estimate a release date.

• Hikma has ampicillin sulbactam 15 gram vials on back order and the company estimates a release date of mid- to late-January 2020. The 1.5 gram and 3 gram vials are on allocation.

• Meitheal Pharmaceuticals has all ampicillin sulbactam presentations on back order and the company estimates a release date of October 2019.

• Pfizer has Unasyn 1.5 gram vials available in limited supply. The 3 gram vials and 15 gram bulk vials are on back order and the company estimates a release date of December 2019. The 1.5 gram and 3 gram ADD-Vantage vials are on back order and the company estimates a release date of October 2019.

• Sagent has ampicillin sulbactam 1.5 gram vials and 15 gram bulk vials on back order and the company cannot estimate a release date. The 3 gram vials are on back order and the company estimates a release date of September 2019.

• WG Critical Care has ampicillin sulbactam 1.5 gram and 3 gram vials on back order and the company estimates a release date in mid- to late-September 2019. The 15 gram vials are on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=159 Vinblastine Sulfate Injection September 6, 2019 Reason for the Shortage

• Fresenius Kabi has vinblastine on shortage due to a short-term manufacturing delay. They are the sole suppliers of vinblastine.

Estimated Resupply Dates • Fresenius Kabi has vinblastine available for direct and drop ship orders.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=578 Multiple Vitamins for Infusion September 6, 2019 Reason for the Shortage

• Pfizer states the shortage is due to manufacturing delays. • Baxter has all presentations fully available at this time.

Estimated Resupply Dates • Pfizer has M.V.I. Adult 2 X 5 mL Dual vials, M.V.I. Adult 2 X 50 mL vials, and Pediatric 5 mL vials on

back order and the company estimates a release date of September 2019 for the Adult 2 x 5 mL vials, November 2020 for the Adult 2 x 50 mL vials, and June 2020 for the Pediatric 5 mL vials.



Midazolam Injection September 6, 2019 Reason for the Shortage

• Athenex did not provide a reason for the shortage. • Fresenius Kabi has midazolam injection on back order due to increased demand. • Hikma has midazolam injection available. • Pfizer has midazolam injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Athenex has midazolam 5 mg/mL 5 mL vials on back order and the company cannot estimate a

release date. • Fresenius Kabi has midazolam 1 mg/mL 10 mL vials and midazolam 5 mg/mL 5 mL vials on back order

and the company cannot estimate a release date. There are short-dated midazolam 5 mg/mL 10 mL vials and 1 mL fill in 2 mL vials available with expiration dates of <9 months.

• Pfizer has midazolam 1 mg/mL 2 mL Carpuject syringes, 1 mg/mL 2 mL iSecure syringes, and 5 mg/mL 1 mL Carpuject syringes on back order and the company estimates a release date of June 2021.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=576 Labetalol Injection September 6, 2019 Reason for the Shortage

• Akorn did not provide a reason for the shortage. • Alvogen did not provide a reason for the shortage. • Fosun has labetalol injection available. • Hikma has labetalol injection on shortage due to increase demand. • Pfizer has labetalol injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Akorn has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company cannot estimate

a release date. • Alvogen has labetalol 5 mg/mL 20 mL vials on allocation. The 40 mL vials are on back order and the

company estimates a release date of mid-September 2019. • Hikma has labetalol 5 mg/mL 20 mL vials on allocation. • Pfizer has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company estimates a

release date of November 2019 for the 20 mL vials and January 2021 for the 40 mL vials. The 5 mg/mL 4 mL Carpuject syringes are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=286 Ketamine Injection September 6, 2019 Reason for the Shortage

• Hikma did not provide a reason for the shortage. • Mylan Institutional has ketamine available. • Par had Ketalar on shortage due to increased demand. • Pfizer has ketamine on shortage due to manufacturing delays.

Estimated Resupply Dates • Hikma has ketamine 50 mg/mL 10 mL and 100 mg/mL 5 mL vials on allocation.


• Pfizer has ketamine 50 mg/mL 10 mL vials on back order and the company estimates a release date of January 2020. The 100 mg/mL 5 mL vials are on back order and the company estimates a release date of November 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=391 Dopamine Hydrochloride Injection September 6, 2019 Reason for the Shortage

• American Regent is not marketing dopamine injection. • Baxter has dopamine premixed bags available. • Pfizer states the shortage is due to manufacturing delays. The dopamine 200 mg/250 mL and 400

mg/500 mL premixed bags were discontinued in August 2017. Estimated Resupply Dates

• Pfizer has dopamine 40 mg/mL 5 mL and 10 mL vials on back order and the company estimates a release date of September 2019 for the 5 mL vials and June 2020 for the 10 mL vials. The 400 mg/250 mL premixed bags are on back order and the company estimates a release date of October 2019. There are short-dated 800 mg/250 mL premixed bags available with an expiration date of October 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=246 Dicyclomine Oral Presentations September 6, 2019 Reason for the Shortage

• Hikma did not provide a reason for the shortage. • Lannett did not provide a reason for the shortage. • Mylan did not provide a reason for the shortage. • Par Pharmaceuticals has dicyclomine oral solution available. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Mylan has dicyclomine 10 mg capsules in 100 count and 500 count on back order and the company

estimates a release date of mid-November 2019 for the 100 count size and early-November 2019 for the 500 count size. The 20 mg capsules in 500 count are on back order and the company estimates a release date of late-October 2019. The 20 mg capsules in 100 count unit-dose packs are on back order and the company estimates a release date of late-September to early-October 2019.

• Teva has 10 mg capsules in 1,000 count on back order and the company estimates a release date of mid-September 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=521 Dexmedetomidine Hydrochloride 100 mcg/mL Vials for Injection September 6, 2019 Reason for the Shortage

• Accord has dexmedetomidine vials available. • Akorn is no longer manufacturing dexmedetomidine vials. • Athenex has dexmedetomidine vials available. • AuroMedics has dexmedetomidine vials available. • Fresenius Kabi did not provide a reason for the shortage. • Hikma did not provide a reason for the shortage.


• Mylan did not provide a reason for the shortage. • Par has dexmedetomidine vials available. • Pfizer has dexmedetomidine vials available. • Sandoz has dexmedetomidine vials available. • Sun Pharma is no longer manufacturing dexmedetomidine. • Teva discontinued dexmedetomidine vials in July 2019. • WG Critical Care has dexmedetomidine vials on back order due to manufacturing delays.

Estimated Resupply Dates • Hikma has dexmedetomidine 100 mcg/mL 2 mL vials on back order and the company estimates a

release date of early-November 2019. • Mylan Institutional has dexmedetomidine 100 mcg/mL 2 mL vials on back order and the company

cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=491 Dexamethasone Sodium Phosphate Injection September 6, 2019 Reason for the Shortage

• American Regent is not marketing dexamethasone sodium phosphate injection at this time. • AuroMedics has dexamethasone sodium phosphate on intermittent back order. • Fresenius Kabi has dexamethasone sodium phosphate presentations available. • Mylan Institutional has dexamethasone injection available. • Hikma did not provide a reason for the shortage. • Somerset Therapeutics has 10 mg/mL 1 mL vials available.

Estimated Resupply Dates • AuroMedics has dexamethasone sodium phosphate 4 mg/mL 1 mL, 5mL, and 30 mL vials on

intermittent back order and the company is releasing product as it becomes available. • Fresenius Kabi has short-dated dexamethasone sodium phosphate 4 mg/mL 1 mL prefilled syringes

available with an expiration date of <7 months. • Hikma has dexamethasone sodium phosphate 4 mg/mL 5 mL vials on back order and the company

estimates a release date of late-October to early-November 2019 https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=140 Carbidopa and Levodopa Extended-Release Tablets September 6, 2019 Reason for the Shortage

• Accord has discontinued carbidopa and levodopa 25 mg/100 mg extended-release tablets. The 50 mg/200 mg tablets are on shortage due to problems obtaining active ingredient.

• Sun Pharma had carbidopa and levodopa extended-release tablets on shortage due to increased demand.

• Merck will be discontinuing Sinemet CR 50 mg/200 mg tablets around November 2019. The 25 mg/100 mL tablets will be discontinued around February 2020.

• Mylan did not provide a reason for the shortage. Estimated Resupply Dates

• Accord has carbidopa and levodopa 50 mg/200 mg extended-release tablets on allocation. • Mylan has carbidopa and levodopa 50 mg/200 mg extended-release tablets in 100 count unit-dose

packs on back order and the company estimates a release date of late-September to early-October 2019.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=349 Thrombin Topical Solution (Bovine) September 9, 2019 Reason for the Shortage

• Pfizer has Thrombin-JMI on shortage due to manufacturing delays. • Recombinant thrombin is not affected by this shortage

Estimated Resupply Dates • Pfizer has Thrombin-JMI 5,000 unit vials and 5,000 unit syringe spray kits available in limited supply.

The 20,000 unit pump spray kits are on back order and the company estimates a release date of September 2019. The 20,000 unit vials are on back order and the company estimates a release date of September 2019. The 20,000 unit syringe spray kits are on back order and the company estimates a release date of September 2019.The 5,000 unit epistaxis kits are on back order and the company estimates a release date of December 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=479 Sterile Water for Injection - Small Volume Vials September 9, 2019 Reason for the Shortage

• American Regent has sterile water for injection available. • Fresenius Kabi had sterile water on shortage due to increased demand. • Hikma has sterile water for injection available. • Pfizer had sterile water for injection in vials on shortage due to increased demand.

Estimated Resupply Dates • Fresenius Kabi has sterile water for injection 100 mL vials on back order and the company estimates

a release date of late-September 2019. The 5 mL vials are on back order and the company estimates a release date of early- to mid-October 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=375 Sodium Acetate Injection September 9, 2019 Reason for the Shortage

• American Regent is not currently marketing sodium acetate injection. • Fresenius Kabi has sodium acetate injection on back order due to increased demand. • Pfizer has sodium acetate injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Fresenius Kabi has sodium acetate 4 mEq/mL 100 mL vials on back order and the company estimates

a release date of early- to mid-September 2019. • Pfizer has sodium acetate 2 mEq/mL 20 mL vials available in limited supply. The 100 mL vials are on

back order and the company estimates a release date of September 2019. The 50 mL vials are on back order and the company estimates a release date of September 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=317 Lidocaine Injection September 9, 2019 Reason for the Shortage

• Amphastar had lidocaine 2% emergency syringes available.


• AuroMedics introduced lidocaine injection in February 2014. • Fresenius Kabi had generic lidocaine presentations on shortage due to a supply interruption of raw

ingredients. • Pfizer has lidocaine presentations on shortage due to manufacturing delays.

Estimated Resupply Dates • AuroMedics has 1% lidocaine 30 mL vials on intermittent back order and the company is releasing

product as it becomes available. AuroMedics has 2% lidocaine 5 mL vials on intermittent back order and the company is releasing product as it becomes available.

• Fresenius Kabi has 1% Xylocaine 50 mL vial on back order and the company estimates a release date of late-September to early-October 2019. The 1% Xylocaine-MPF 30 mL vial sterile packs are on back order and the company cannot estimate a release date. The 1.5% Xylocaine-MPF 20 mL ampules are on back order and the company cannot estimate a release date. The 2% Xylocaine-MPF 10 mL ampules are on back order and the company estimates a release date of late-October 2019. Check wholesalers for inventory.

• Hikma has 2% lidocaine 5 mL vials on back order and the company estimates a release date of late-October to early-November 2019.

• Pfizer has 1% lidocaine 5 mL preservative-free ampules on back order and the company estimates a release date of March 2020. The 1% lidocaine 30 mL preservative-free vials are on back order and the company estimates a release date of September 2019. The 1% lidocaine 5 mL Lifeshield syringes are on back order and the company estimates a release date of October 2019. The 1.5% lidocaine 20 mL preservative-free ampules are on back order and the company estimates a release date of February 2020. The 2% lidocaine 5 mL vials are on back order and the company estimates a release date of September 2019. The 2% lidocaine 5 mL Lifeshield syringes are on back order and the company estimates a release date of October 2019. The 2% lidocaine 5 mL Ansyr syringes are on back order and the company estimates a release date of December 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=88 Hydromorphone Hydrochloride Injection September 9, 2019 Reason for the Shortage

• Akorn has hydromorphone injection on shortage due to increased demand. • Fresenius Kabi has Dilaudid syringes on shortage due to increased demand. They are focusing their

product on the 0.5 mg strength. They launched hydromorphone vials in late-June 2018. • Pfizer did not provide a reason for the shortage. • Purdue discontinued Dilaudid and Dilaudid HP in May 2017 for marketing reasons. • Teva did not provide a reason for the shortage. • Hikma did not provide a reason for the shortage.

Estimated Resupply Dates • Fresenius Kabi has Dilaudid 2 mg/mL 1 mL syringes on back order and the company estimates a

release date of mid-September 2019. The hydromorphone 4 mg/mL 1 mL vials are on back order and the company estimates a release date of early- to mid-September 2019. The hydromorphone 10 mg/mL 50 mL vials are on back order and the company estimates a release date of late-October 2019. Check wholesalers for inventory.

• Pfizer has 2 mg/mL 1 mL vials available in limited supply. The 10 mg/mL 1 mL vials are on back order and the company estimates a release date of October 2019. The 0.5 mg/0.5 mL iSecure syringes are available in limited supply. The 1 mg/mL 1 mL ampules, 2 mg/mL 1 mL ampules, and 4 mg/mL 1 mL ampules are on back order and the company estimates a release date of September 2019 for the 1


mL ampules, April 2020 for the 2 mL ampules, and November 2019 for the 4 mL ampules. The 1 mg/mL 1 mL iSecure syringes and 2 mg/mL 1 mL iSecure syringes are on back order and the company estimates a release date of January 2020. The 4 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of January 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=329 Furosemide Injection September 9, 2019 Reason for the Shortage

• American Regent is not actively marketing furosemide injection. • Amneal discontinued furosemide injection. • Baxter has furosemide injection available. • Fresenius Kabi did not provide a reason for the shortage. • Heritage did not provide a reason for the shortage. • Pfizer had furosemide injection on shortage due to manufacturing delays and increased demand.

Estimated Resupply Dates • Fresenius Kabi has furosemide 10 mg/mL 10 mL vials on back order and the company estimates a

release date of late-October 2019. • Heritage has furosemide 10 mg/mL 2 mL, 4 mL, and 10 mL vials on back order with no estimated

release date. • Pfizer has furosemide 10 mg/mL 4 mL and 10 mL syringes on back order and the company estimates

a release date of December 2019. There are short-dated 10 mL vials available with an expiration date of October 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=323 Fludrocortisone Acetate Tablets September 9, 2019 Reason for the Shortage

• Amneal did not provide a reason for the shortage. • Teva has fludrocortisone tablets available.

Estimated Resupply Dates • Amneal has fludrocortisone acetate 0.1 mg tablets in 100 count on back order and the company

cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=484 Bupivacaine with Epinephrine Injection September 9, 2019 Reason for the Shortage

• Fresenius Kabi has bupivacaine and epinephrine on shortage due to increased demand and manufacturing delays.

• Pfizer has bupivacaine with epinephrine on shortage due to manufacturing delays Estimated Resupply Dates

• Fresenius Kabi has 0.25% Sensorcaine-MPF with epinephrine 10 mL vials on back order and the company estimates a release date of late-September to early-October 2019. The 0.25% Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of late-September 2019. The 0.5% Sensorcaine-MPF with epinephrine 10 mL vials are on back order and the company estimates a release date of late-September to early-October 2019. The 0.5%


Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of early- to mid-September 2019. The 0.5% Sensorcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of early- to mid-September 2019. The 0.5% Sensorcaine-MPF with epinephrine 30 mL sterile packs are on back order and the company cannot estimate a release date.

• Pfizer has 0.25% bupivacaine with epinephrine 10 mL preservative-free vials on back order and the company estimates a release date of February 2020. The 0.25% bupivacaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of December 2019. The 0.25% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of December 2019. The 0.5% bupivacaine with epinephrine 10 mL preservative-free vials are on back order and the company estimates a release date of March 2020. The 0.5% bupivacaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of December 2019.The 0.5% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of March 2020.

• Pfizer has 0.25% Marcaine with epinephrine 10 mL preservative-free vials on back order and the company estimates a release date of October 2019. The 0.25% Marcaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of September 2019. The 0.25% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of September 2019. The 0.5% Marcaine with epinephrine 10 mL preservative-free vials are on back order and the company estimates a release date of January 2020. The 0.5% Marcaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of June 2021. The 0.5% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of September 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=261 Bupivacaine Injection September 9, 2019 Reason for the Shortage

• AuroMedics has not provided a reason for the shortage. • Fresenius Kabi had Sensorcaine on shortage due to increased demand for the product. • Pfizer has bupivacaine on shortage due to manufacturing delays. Pfizer discontinued 0.5%

bupivacaine 30 mL glass ampules in December 2017. Estimated Resupply Dates

• AuroMedics has 0.25% bupivacaine 10 mL and 30 mL preservative-free vials on intermittent back order and the company is releasing product as it becomes available. The 0.5% bupivacaine 10 mL and 30 mL preservative-free vials are on intermittent back order and the company is releasing product as it becomes available. The 0.75% bupivacaine 10 mL and 30 mL preservative-free vials are on intermittent back order and the company is releasing product as it becomes available.

• Fresenius Kabi has 0.25% Sensorcaine 30 mL preservative-free vials on back order and the company estimates a release date of late-September 2019. The 0.25% and 0.5% Sensorcaine 30 mL preservative-free vials in sterile packs are on back order and the company cannot estimate release dates.

• Pfizer has 0.25% bupivacaine 10 mL preservative-free vials on back order and the company estimates a release date of December 2019. The 0.25% bupivacaine 30 mL preservative-free vials are available in limited supply. The 0.25% bupivacaine 50 mL vials are on back order and the company estimates a release date of September 2019. The 0.5% bupivacaine 10 mL preservative-free vials are on back order and the company estimates a release date of November 2019. The 0.5% bupivacaine 30 mL preservative-free vials are on back order and the company estimates a release date of September


2019. The 0.5% bupivacaine 50 mL vials are on back order and the company estimates a release date of September 2019. The 0.75% bupivacaine 10 mL preservative-free vials are on back order and the company estimates a release date of December 2019. The 0.75% bupivacaine 30 mL preservative-free vials are on back order and the company estimates a release date of September 2019.

• Pfizer has 0.25% Marcaine 10 mL and 30 mL preservative-free vials on back order and the company estimates a release date of April 2020 for the 10 mL vials and November 2019 for the 30 mL vials. The 0.25% 50 mL vials are on back order and the company estimates a release date of January 2020. The 0.5% Marcaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of January 2020. The 0.5% 50 mL vials are on back order and the company estimates a release date of December 2019. The 0.75% Marcaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of December 2019 for the 10 mL vials and November 2019 for the 30 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=172 Acetylcysteine Oral and Inhalation Solution September 9, 2019 Reason for the Shortage

• American Regent has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays.

• Arbor discontinued Cetylev effervescent tablets in April 2019. • Fresenius Kabi has acetylcysteine oral and inhalation solution available. • Pfizer has acetylcysteine oral and inhalation solution available. • Roxane Labs discontinued acetylcysteine oral and inhalation solution in April 2014.

Estimated Resupply Dates • American Regent has acetylcysteine solution 200 mg/mL 30 mL vials on back order and the company

cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=43 23.4% Sodium Chloride Injection September 9, 2019 Reason for the Shortage

• Fresenius Kabi had 23.4% sodium chloride injection on shortage due to increased demand. • Pfizer has 23.4% sodium chloride injection on shortage due to increased demand.

Estimated Resupply Dates • Pfizer has 23.4% sodium chloride 200 mL vials on back order and the company estimates a release

date of December 2019. • Fresenius Kabi has 23.4% sodium chloride 200 mL vials on back order and the company estimates a

release date of late-September 2019 https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=336 Sincalide Injection September 10, 2019 Reason for the Shortage

• Bracco Diagnostics has Kinevac injection available. Estimated Resupply Dates

• N/A https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=277


Cosyntropin Injection September 10, 2019 Reason for the Shortage

• Amphastar has Cortrosyn on shortage due to increased demand. • Mylan Institutional refuses to provide availability information. • Sandoz did not provide a reason for the shortage

Estimated Resupply Dates • Amphastar and Sandoz have cosyntropin available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=522 Bumetanide Injection September 10, 2019 Reason for the Shortage

• Pfizer has bumetanide injection on shortage due to manufacturing delays. • Hikma has bumetanide injection available.

Estimated Resupply Dates • Pfizer has bumetanide 0.25 mg/mL 4 mL and 10 mL vials on back order and the company estimates a

release date of December 2019 for the 4 mL vials and March 2020 for the 10 mL vials. • Hikma has bumetanide 0.25 mg/mL 4 mL vials on back order and the company estimates a release

date of late September 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=307 Acyclovir Injection September 10, 2019 Reason for the Shortage

• AuroMedics did not provide a reason for the shortage. • Fresenius Kabi has acyclovir injection on shortage due to increased demand.

Estimated Resupply Dates • AuroMedics has acyclovir 50 mg/mL 10 mL and 20 mL vials on intermittent back order and the

company is releasing product as it becomes available. • Fresenius Kabi has acyclovir 50 mg/mL 10 mL and 20 mL vials on back order and the company

estimates a release date of late-October 2019 for the 10 mL vials and early-October 2019 for the 20 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=590 Verapamil Extended-Release Tablets September 11, 2019 Reason for the Shortage

• Glenmark did not provide a reason for the shortage. • Mylan refuses to provide availability information. • Pfizer did not provide a reason for the shortage.

Estimated Resupply Dates • Glenmark has verapamil 120 mg extended-release tablets in 100 count and 180 mg extended-release

tablets in 500 count on back order and the company estimates a release date of late-September 2019 for the 120 mg extended-release tablets and mid- to late-September 2019 for the 180 mg extended-release tablets.


• Pfizer has Calan SR 240 mg extended-release tablets in 100 count on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=555 Venlafaxine Hydrochloride Extended-Release Capsules September 11, 2019 Reason for the Shortage

• Teva and Zydus did not provide a reason for the shortage. • Pfizer has Effexor XR capsules available. • Zydus has discontinued the 30 count presentations.

Estimated Resupply Dates • Teva has venlafaxine 37.5 mg and 150 mg extended-release capsules in 500 count bottles, 150 mg

extended-release capsules in 90 count bottles, and 37.5 mg extended-release capsules in 30 count bottles on back order and the company estimates a release date in early-October 2019. The 37.5 mg extended-release capsules in 90 count bottles are on intermittent back order and the company is releasing supplies as they become available.

• Zydus has all venlafaxine extended-release capsule presentations on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=587 Testosterone Cypionate Injection September 11, 2019 Reason for the Shortage

• Hikma and Perrigo did not provide a reason for the shortage. • Pfizer did not provide a reason for the shortage of Depo-Testosterone. • Sun Pharma has testosterone cypionate injection available.

Estimated Resupply Dates • Perrigo has testosterone cypionate 200 mg/mL 1 mL vials on intermittent back order and the

company is releasing supplies as they become available. The 200 mg/mL 10 mL vials are on back order and the company cannot estimate a release date.

• Pfizer has Depo-Testosterone 200 mg/mL 1 mL vials on intermittent back order and the company is releasing supplies as they become available. The 100 mg/mL 10 mL vials and 200 mg/mL 10 mL (NDC 00009-0417-02) vials are available in limited supply.

• Hikma has testosterone cypionate 200 mg/mL 1 mL vials on allocation. The 200 mg/mL 10 mL vials are on back order and the company estimates a release date in mid- to late-November 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=592 Rabies Immune Globulin September 11, 2019 Reason for the Shortage

• Sanofi Pasteur has Imogam Rabies-HT on shortage due to manufacturing delays. Estimated Resupply Dates

• Sanofi Pasteur has Imogam Rabies-HT available with ordering restrictions. Access post-exposure information via link on the VACCINESHOPPE home page found at https://www.vaccineshoppe.com/.



Prednisone Oral Tablets September 11, 2019 Reason for the Shortage

• Cadista, Hikma, Par, and Teva did not provide a reason for the shortage. Estimated Resupply Dates

• Cadista has all prednisone tablet presentations on allocation. • Hikma has most prednisone tablet presentations on allocation. • Teva has prednisone 5 mg and 10 mg tablets in 21 and 48 count bottles on back order and the

company estimates a release date in late-September 2019. Prednisone 10 mg and 20 mg tablets in 100 and 1000 count bottles are on back order and the company estimates a release date in late-October 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=563 Pantoprazole Injection September 11, 2019 Reason for the Shortage

• AuroMedics has pantoprazole injection on shortage due to increased demand. • Hikma did not provide a reason for the shortage. • Pfizer has Protonix injection on shortage due to manufacturing delays.

Estimated Resupply Dates • AuroMedics has pantoprazole 40 mg vials on intermittent back order and the company is releasing

product as it becomes available. • Hikma has pantoprazole 40 mg vials on allocation. • Pfizer has Protonix 25 mg vials in 25 count and 40 mg vials in 10 count on back order and the

company estimates release dates in September 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=550 Nitrofurantoin Oral Suspension September 11, 2019 Reason for the Shortage

• Amneal stated the shortage of nitrofurantoin oral suspension is due to manufacturing delays. • Casper Pharma stated the Furadantin shortage is due to manufacturing delays. • Lupin is no longer manufacturing this product. • Nostrum has nitrofurantoin oral suspension available. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Amneal has nitrofurantoin oral suspension temporarily unavailable and the company cannot

estimate a release date. • Casper has Furadantin oral suspension on back order and the company cannot estimate a release

date. • Teva has nitrofurantoin oral suspension temporarily unavailable and the company cannot estimate a

release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=433


Midodrine Tablets September 11, 2019 Reason for the Shortage

• Apotex has midodrine tablets available. • Impax discontinued midodrine tablets in July 2018. • Mylan refuses to provide availability updates. • Sandoz discontinued midodrine tablets in mid-2018. • Upsher-Smith has midodrine tablets available.

Estimated Resupply Dates • No information available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=439 Lidocaine with Epinephrine Injection September 11, 2019 Reason for the Shortage

• Fresenius Kabi has Xylocaine with epinephrine presentations on shortage due to increased demand for the product and manufacturing delays.

• Pfizer has lidocaine with epinephrine presentations on shortage due to manufacturing delays. Estimated Resupply Dates

• Fresenius Kabi has 1% Xylocaine with epinephrine (1:200,000) 10 mL vials on back order and the company estimates release dates of mid-September 2019. The 1% Xylocaine with epinephrine (1:200,000) 20 mL vials are on back order and the company estimates release dates of late-September 2019. The 1% Xylocaine with epinephrine (1:200,000) 50 mL vials are on back order and the company estimates release dates of early- to mid-September 2019. The 1% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials are on back order and the company estimates release dates of early- to mid-September 2019. The 1% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot estimate a release date. The 1.5% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot estimate a release date. The 2% Xylocaine with epinephrine (1:200,000) 20 mL vials are on back order and the company estimates a release date of mid-September 2019. The 2% Xylocaine with epinephrine (1:200,000) 50 mL vials are on back order and the company estimates a release date of late-September 2019. The 2% Xylocaine-MPF with epinephrine (1:200,000) 20 mL vials in sterile packs are on back order and the company cannot estimate a release date. Check wholesalers for inventory.

• Pfizer has 0.5% lidocaine with epinephrine (1:100,000) 20 mL vials on back order and the company estimates a release date of September 2019. The 1% lidocaine with epinephrine (1:100,000) 50 mL vials are on back order and the company estimates a release date of September 2019. The 2% lidocaine with epinephrine (1:100,000) 30 mL vials are on back order and the company estimates a release date of November 2019. The 2% lidocaine with epinephrine (1:100,000) 50 mL vials are on back order and the company estimates a release date of September 2019. The 2% lidocaine with epinephrine (1:200,000) 20 mL vials are on back order and the company estimates a release date of September 2019.



Levetiracetam Injection September 11, 2019 Reason for the Shortage

• American Regent did not provide a reason for the shortage. • Athenex did not provide a reason for the shortage. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi has product available. • Mylan refuses to provide updated availability information. • Pfizer did not provide a reason for the shortage. • Sagent has product available. • Sun Pharma did not provide a reason for the shortage. • UCB has product available. • Hikma did not provide a reason for the shortage. • X-Gen has product available.

Estimated Resupply Dates • Athenex has levetiracetam 10 mg/mL and 15 mg/mL 100 mL premixed bags on allocation. • AuroMedics has levetiracetam 5 mg/mL 100 mL, 10 mg/mL 100 mL, and 15 mg/mL 100 mL premixed

bags on back order and the company cannot estimate a release date. • Hikma has levetiracetam 100 mg/mL 5 mL vials on back order and the company estimates a release

date in early-October 2019. • Pfizer has levetiracetam 100 mg/mL 5 mL vials available in limited supply. • Sun Pharma has levetiracetam 100 mg/mL 5 mL vials on back order and the company cannot

estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=84 Leucovorin Calcium Injection September 11, 2019 Reason for the Shortage

• Fresenius Kabi had leucovorin on shortage due to manufacturing delays and increased demand. • Hikma did not provide a reason for the current shortage. • Mylan refuses to provide availability information. • Sagent has leucovorin on shortage due to manufacturing delays. • Teva has leucovorin available.

Estimated Resupply Dates • Fresenius Kabi has leucovorin 200 mg and 500 mg vials on back order and the company estimates a

release date of mid-September 2019. Leucovorin 10 mg/mL 10 mL vials are on back order and the company estimates a release date of 4th quarter 2019.

• Hikma has leucovorin 50 mg, 100 mg, 200 mg, and 350 mg vials on allocation. • Sagent has leucovorin 50 mg, 100 mg, 200 mg, 350 mg, and 500 mg vials on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=35 Furosemide Tablets September 11, 2019 Reason for the Shortage

• Major discontinued furosemide tablets in early-2018. • Mylan did not provide a reason for the shortage. • Hikma states the shortage is due to manufacturing delays.


• Sandoz discontinued furosemide tablets in late-August 2017. • Teva discontinued furosemide tablets in June 2018

Estimated Resupply Dates • Mylan has furosemide 20 mg tablets in 1,000 count on back order and the company estimates a

release date of mid-September 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=339 Busulfan Injection September 11, 2019 Reason for the Shortage

• American Regent did not provide a reason for the shortage. • Amneal has busulfan injection available. • Apotex launched busulfan injection in August 2019. • Athenex launched busulfan injection in March 2019. • Mylan Institutional has busulfan injectable available. • Sagent has busulfan injection available. • Teva has busulfan injection available. • Otsuka has Busulfex available.

Estimated Resupply Dates • American Regent has busulfan 6 mg/mL 10 mL vials on back order and the company cannot estimate

a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=509 Bivalirudin Injection September 11, 2019 Reason for the Shortage

• Accord has temporarily discontinued bivalirudin. • Apotex has discontinued bivalirudin. • AuroMedics did not provide a reason for the shortage. • Baxter has 250 mg/50 mL bivalirudin premixed bags available. The company is not actively producing

the 500 mg/100 mL bags due to low demand. • Dr. Reddy's did not provide a reason for the shortage. • Fresenius Kabi did not provide a reason for the shortage. • Pfizer has bivalirudin on shortage due to manufacturing delays. • Sandoz did not provide a reason for the shortage.

Estimated Resupply Dates • AuroMedics has bivalirudin 250 mg vials on allocation. • Dr. Reddy's has bivalirudin 250 mg vials on allocation. • Pfizer has bivalirudin 250 mg vials available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=569 Asparaginase Erwinia chrysanthemi September 11, 2019 Reason for the Shortage

• Erwinaze supply disruption is due to ongoing manufacturing issues and capacity constraints at Porton Biopharma Limited, the sole manufacturer of Erwinaze. Erwinaze is distributed by Jazz Pharmaceuticals.


Estimated Resupply Dates • Jazz Pharmaceuticals has Erwinaze 10,000 unit vials in 1 count and 5 count on back order and the

company cannot estimate a release date. • There is a new process for ordering Erwinaze. Additional information regarding the new ordering

process is available at www.erwinazesupply.com. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=482 Sodium Bicarbonate Injection September 12, 2019 Reason for the Shortage

• Amphastar has sodium bicarbonate injection on shortage due to increased demand. • Athenex has sodium bicarbonate available. • Pfizer has sodium bicarbonate injection on shortage due to manufacturing delays. • Fresenius Kabi had sodium bicarbonate injection temporarily available, but have run out of stock,

there is more in production at this time. Estimated Resupply Dates

• Amphastar has 8.4% sodium bicarbonate 50 mL syringes on allocation. • Fresenius Kabi has 8.4% sodium bicarbonate 50 mL vials on back order and the company estimates a

release date of early-September 2019. • Pfizer has 4.2% and 8.4% sodium bicarbonate 10 mL syringes on back order and the company

estimates a release date of October 2019. The 7.5% 50 mL syringes are on back order and the company estimates a release date of November 2019. The 8.4% 50 mL LifeShield syringes are on back order and the company estimates a release date of September 2019.

• Pfizer has Neut 4% 5 mL vials on back order and the company estimates a release date of December 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=293 Morphine Injection September 12, 2019 Reason for the Shortage

• Fresenius Kabi procured morphine syringes from BD in 2016. They discontinued the 8 mg/mL and 10 mg/mL 1 mL syringes in early-2018.

• Astramorph injection has been unavailable since 2012. Fresenius Kabi changed manufacturing sites and cannot estimate if Astramorph will return.

• Pfizer has a shortage of several prefilled syringe products, including morphine, starting in late-July 2017 due to issues at a manufacturing facility. To minimize the impact of the shortage, Pfizer is prioritizing production of certain morphine Carpuject syringes.

• Hikma did not provide a reason for the shortage. • Piramal Critical Care has Mitigo 10 mg/mL 20 mL and 25 mg/mL 20 mL vials available.

Estimated Resupply Dates • Fresenius Kabi has morphine 5 mg/mL 1 mL syringes on back order and the company estimates a

release date of early- to mid-October 2019. The 5 mg/mL 1 mL vials and 8 mg/mL 1 mL vials are on back order and the company estimates a release date of mid-September 2019. Check wholesalers for inventory.

• Pfizer has morphine 1 mg/mL 10 mL preservative-free vials on back order and the company estimates a release date of September 2019. The 2 mg/mL 1 mL iSecure syringes, 4 mg/mL 1 mL iSecure syringes, 8 mg/mL 1 mL iSecure syringes, and 10 mg/mL 1 mL iSecure syringes are on back


order and the company estimates a release date of August 2020. The 8 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of December 2019. The 10 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of December 2019. The 25 mg/mL 1 mL preservative-free vials are on back order and the company estimates a release date of March 2020. The 50 mg/mL 50 mL vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=41 Methotrexate Injection September 12, 2019 Reason for the Shortage

• Accord has methotrexate injection on back order due to increased demand. • Fresenius Kabi did not provide a reason for the shortage. • Mylan Institutional refuses to provide product availability. • Pfizer has methotrexate injection available. • Teva did not provide a reason for the shortage. • Hikma has methotrexate injection available.

Estimated Resupply Dates • Fresenius Kabi has methotrexate 1 gram vials of lyophilized powder for solution on back order and

the company estimates a release date of late-September 2019. • Teva has methotrexate 25 mg/mL 40 mL preservative-free vials on allocation. Check availability with

wholesalers. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=282 Meperidine Hydrochloride Injection September 12, 2019 Reason for the Shortage

• Pfizer has Demerol injection on shortage due to manufacturing delays. • ICU Medical discontinued meperidine 30 mL PCA vials.

Estimated Resupply Dates • Pfizer has Demerol 100 mg/mL 20 mL vials and on back order and the company estimates a release

date of June 2020. The 25 mg/mL 1 mL Carpuject syringes, 50 mg/mL 1 mL Carpuject syringes, 75 mg/mL 1 mL Carpuject syringes, 100 mg/mL 1 mL Carpuject syringes, and 50 mg/mL 1 mL and 1.5 mL ampules are on back order and the company estimates a release date of October 2020. The 100 mg/mL 1 mL ampules are on back order and the company estimates a release date of September 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=347 Loxapine Tablets September 12, 2019 Reason for the Shortage

• TEVA has loxapine tablets on shortage and did not provide a reason. • Marlex has loxapine tablets on shortage and did not provide a reason. • Lannett has loxapine tablets on shortage due to manufacturing delays. • Mylan Institutional has loxapine tablets on shortage and did not provide a reason.

Estimated Resupply Dates • TEVA has loxapine 5 mg, 10 mg, and 50 mg tablets on back order and the company estimates a

resupply date in September 2019.


• Marlex has loxapine 5 mg, 10 mg, 25 mg, and 50 mg tablets on back order and the company cannot estimate a resupply date.

• Lannett has loxapine 5 mg on backorder and the company estimates a resupply date in February 2020. The 10 mg, 25 mg, and 50 mg tablets are also on back order and the company cannot estimate a resupply date.

• Mylan Institutional has loxapine 5 mg, 10 mg, 25 mg, and 50 mg tablets on back order and the company estimates a resupply date in late-January 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=593 Doxycycline Hyclate Injection September 12, 2019 Reason for the Shortage

• Mylan Institutional did not provide a reason for the shortage. • Zydus discontinued doxycycline injection in mid-2019.

Estimated Resupply Dates • Mylan Institutional has doxycycline 100 mg vials on back order and the company estimates a release

date of late-September 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=559 Ciprofloxacin Oral Suspension September 12, 2019 Reason for the Shortage

• Lupin did not provide a reason for the shortage. • Bayer has Cipro oral suspension available.

Estimated Resupply Dates • Lupin has ciprofloxacin oral suspension on long-term back order and the company cannot estimate a

release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=255 Ceftazidime Injection September 12, 2019 Reason for the Shortage

• Pfizer has Tazicef available. • Sagent has ceftazidime injection on shortage due to increased demand and manufacturing delays. • BBraun had ceftazidime on allocation due to increased demand. • Teligent discontinued Fortaz 2 gram vials, 6 gram vials, and both 1 gram/50 mL and 2 gram/50 mL

premixes in February 2018. They also discontinued the 1 gram and 2 gram Twistvials in April 2019. The Fortaz 500 mg and 1 gram vials are on back order due to manufacturing delays.

• WG Critical Care has ceftazidime available. Estimated Resupply Dates

• Pfizer has Tazicef 1 gram vials on back order and the company estimates a release date of September 2019. The 6 gram fliptop vials are available in limited supply with a short expiration dating (December 2019).

• Sagent has ceftazidime 2 gram and 6 gram vials on back order and the company estimates a release date of September 2019. The 1 gram vials are available with short expiration dating (December 2019).



Ropivacaine Injection September 13, 2019 Reason for the Shortage

• Akorn has ropivacaine on shortage due to increased demand. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi has Naropin on shortage due to increased demand and manufacturing delays. • Pfizer had ropivacaine on shortage due to manufacturing delays. • Sagent has ropivacaine premixed bags available. • Somerset Therapeutics has ropivacaine 5 mg/mL 30 mL vials available.

Estimated Resupply Dates • Akorn has ropivacaine 5 mg/mL 30 mL vials on back order and the company cannot estimate a

release date. • AuroMedics has ropivcaine 10 mg/mL 10 mL and 20 mL vials and 2 mg/mL 100 mL bottles on

intermittent back order and the company is releasing product as it becomes available. • Fresenius Kabi has Naropin 5 mg/mL 30 mL Steripak ampules on back order and the company

estimates a release date of mid-October 2019. The 5 mg/mL 20 mL Steripak ampules are on back order and the company cannot estimate a release date. Check wholesalers for inventory.

• Pfizer has ropivacaine 2 mg/mL 10 mL and 20 mL vials on back order and the company estimates a release date of November 2019 for the 10 mL vials and October 2019 for the 20 mL vials. The 5 mg/mL 30 mL vials are on back order and the company estimates a release date of October 2019. The 7.5 mg/mL 20 mL vials are on back order and the company estimates a release date of November 2019. The 10 mg/mL 10 mL and 20 mL vials are on back order and the company estimates a release date of November 2019 for the 10 mL vials and October 2019 for the 20 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=384 Piperacillin and Tazobactam Injection September 13, 2019 Reason for the Shortage

• Apollo Pharmaceuticals has piperacillin/tazobactam injection available. • Apotex has piperacillin/tazobactam did not provide a reason for the shortage. • Athenex has piperacillin/tazobactam injection available. • AuroMedics has piperacillin/tazobactam injection available. • Baxter has piperacillin/tazobactam did not provide a reason for the shortage. • Fresenius Kabi has piperacillin/tazobactam injection available. • Mylan Institutional did not provide a reason for the shortage. • Pfizer has Zosyn single dose vials and piperacillin/tazobactam on shortage due to manufacturing

delays. • Sagent has piperacillin/tazobactam injection on shortage due to increased demand. • Sandoz has piperacillin/tazobactam injection available. • WG Critical Care has piperacillin/tazobactam injection available. • Wockhardt has piperacillin/tazobactam injection available. • X-Gen has piperacillin/tazobactam injection available.

Estimated Resupply Dates • Baxter has Zosyn 2.25 gram and 4.5 gram frozen premixed bags available in limited supply. • Mylan has piperacillin/tazobactam 4.5 gram vials on back order and the company estimates a release

date of September 2019.


• Pfizer has Zosyn 2.25 gram vials, 3.375 gram vials, 4.5 gram vials, and 40.5 gram vials on back order and the company estimates a release date of March 2020.

• Sagent has piperacillin/tazobactam 2.25 gram and 4.5 gram vials on back order and the company estimates a release date of October 2019. There are short-dated 2.25 gram vials available with an expiration date of October 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=158 Lorazepam Injection September 13, 2019 Reason for the Shortage

• Bedford discontinued lorazepam injection in May, 2011. • Hikma has product on shortage due to manufacturing delays. • Pfizer has product on shortage due to increased demand and manufacturing delays. Pfizer

discontinued 4 mg/mL 10 mL vials in December 2017. • Akorn has not provided a reason for the shortage. • Amphastar has product available.

Estimated Resupply Dates • Hikma has lorazepam 2 mg/mL 1 mL vials on back order and the company estimates a release date of

late-September 2019. • Pfizer has lorazepam 4 mg/mL 1 mL Carpuject syringes on back order and the company estimates a

release date of January 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=87 Temazepam Capsules September 16, 2019 Reason for the Shortage

• Ascend did not provide a reason for the shortage. • Major had temazepam on shortage due to manufacturing delays. • Mylan refuses to provide availability information. • Sun Pharma discontinued temazepam capsules in 2019. • Teva did not provide a reason for the shortage. • Mallinckrodt has Restoril capsules available.

Estimated Resupply Dates • Ascend has temazepam 15 mg and 30 mg capsules in 500 count bottles on intermittent back order

and the company is releasing supplies as they become available. • Sun Pharma discontinued temazepam 7.5 mg and 22.5 mg capsules.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=503 Rabies Vaccine September 16, 2019 Reason for the Shortage

• Sanofi Pasteur has Imovax rabies vaccine on shortage due to increased demand. • GlaxoSmithKline did not provide a reason for the shortage.

Estimated Resupply Dates • Sanofi Pasteur has Imovax rabies vaccine available with ordering restrictions. • GlaxoSmithKline has RabAvert rabies vaccine on back order and the company estimates a release

date of late-October 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=594


PCA Sterile Empty Vials and Injector September 16, 2019 Reason for the Shortage

• ICU Medical has LifeCare PCA sterile empty vials and injectors on shortage due to manufacturing delays.

Estimated Resupply Dates • ICU Medical has LifeCare PCA sterile empty vials and injectors on allocation to contracted customers.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=493 Morphine PCA Vials September 16, 2019 Reason for the Shortage

• ICU Medical has morphine PCA vials on shortage due to manufacturing delays. • Amphastar's morphine PCA vials are not affected by the shortage.

Estimated Resupply Dates • ICU Medical has morphine 1 mg/mL 30 mL PCA vials and 5 mg/mL 30 mL PCA vials on back order and

the company estimates a release date of late-April 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=436 Atropine Ophthalmic Solution September 16, 2019 Reason for the Shortage

• Akorn did not provide a reason for the atropine ophthalmic solution shortage. • Altaire has homatropine ophthalmic solution available.

Estimated Resupply Dates • Akorn has short-dated 1% atropine 5 mL and 15 mL bottles available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=514 Tropicamide 1% Ophthalmic Solution September 17, 2019 Reason for the Shortage

• Akorn did not provide a reason for the shortage of tropicamide 1% ophthalmic drops. • Alcon has Mydriacyl available. • Bausch Health discontinued tropicamide 1% ophthalmic drops in mid-2018. • Sandoz has tropicamide 1% ophthalmic drops available.

Estimated Resupply Dates • Akorn has tropicamide 1% ophthalmic drops in 15 mL bottles on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=547 Testosterone Cypionate Injection September 17, 2019 Reason for the Shortage

• Cipla has testosterone cypionate injection on back order because the company is changing NDC numbers.

• Hikma and Perrigo did not provide a reason for the shortage. • Pfizer did not provide a reason for the shortage of Depo-Testosterone.


• Sun Pharma has testosterone cypionate injection available. Estimated Resupply Dates

• Cipla has testosterone cypionate injection on back order and the company cannot estimate a release date.

• Hikma has testosterone cypionate 200 mg/mL 1 mL vials on allocation. The 200 mg/mL 10 mL vials are on back order and the company estimates a release date in mid- to late-November 2019.

• Perrigo has testosterone cypionate 200 mg/mL 1 mL vials on intermittent back order and the company is releasing supplies as they become available. The 200 mg/mL 10 mL vials are on back order and the company cannot estimate a release date.

• Pfizer has Depo-Testosterone 200 mg/mL 1 mL vials on intermittent back order and the company is releasing supplies as they become available. The 100 mg/mL 10 mL vials and 200 mg/mL 10 mL (NDC 00009-0417-02) vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=592 Sodium Bicarbonate Injection September 17, 2019 Reason for the Shortage

• Amphastar has sodium bicarbonate injection on shortage due to increased demand. • Athenex has sodium bicarbonate available. • Pfizer has sodium bicarbonate injection on shortage due to manufacturing delays. • Fresenius Kabi had sodium bicarbonate injection temporarily available, but have run out of stock,

there is more in production at this time. Estimated Resupply Dates

• Amphastar has 8.4% sodium bicarbonate 50 mL syringes on allocation. • Fresenius Kabi has 8.4% sodium bicarbonate 50 mL vials on back order and the company estimates a

release date of late-September 2019. • Pfizer has 4.2% and 8.4% sodium bicarbonate 10 mL syringes on back order and the company

estimates a release date of October 2019. The 7.5% 50 mL syringes are on back order and the company estimates a release date of November 2019. The 8.4% 10 mL syringes and 50 mL LifeShield syringes are available in limited supply.

• Pfizer has Neut 4% 5 mL vials on back order and the company estimates a release date of December 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=293 Recombinant Zoster Vaccine (Shingrix) September 17, 2019 Reason for the Shortage

• GlaxoSmithKline has Shingrix on shortage due to high demand for the product. Estimated Resupply Dates

• GlaxoSmithKline has Shingrix on intermittent back order and the company is shipping orders according to order date and supply available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=427 Prednisone Oral Tablets September 17, 2019 Reason for the Shortage

• Cadista, Hikma, Par, and Teva did not provide a reason for the shortage.



Estimated Resupply Dates • Cadista has all prednisone tablet presentations on allocation. • Hikma has most prednisone tablet presentations on allocation. • Par has prednisone 2.5 mg tablets in 100 count bottles and 10 mg tablets in 21 count blister packs on

back order and the company cannot estimate a release date. • Teva has prednisone 5 mg and 10 mg tablets in 21 and 48 count bottles on back order and the

company estimates a release date in late-September 2019. Prednisone 10 mg and 20 mg tablets in 100 and 1000 count bottles are on back order and the company estimates a release date in late-October 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=563 Prednisolone Acetate 1% Ophthalmic Suspension September 17, 2019 Reason for the Shortage

• Allergan has Pred Forte available. • Greenstone did not provide a reason for the shortage. • Novartis discontinued Omnipred 1% in 2018. • Sandoz had prednisolone acetate ophthalmic suspension available.

Estimated Resupply Dates • Greenstone has all prednisolone acetate 1% presentations on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=536 Olanzapine Intramuscular Injection September 17, 2019 Reason for the Shortage

• American Regent did not provide a reason for the shortage. • Lilly has Zyprexa intramuscular injection available. • Sandoz did not provide a reason for the shortage.

Estimated Resupply Dates • American Regent has olanzapine 10 mg vials for intramuscular injection available in limited supply. • Sandoz has olanzapine 10 mg vials on back order and the company estimates a release date in late-

September 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=492 Nelarabine Injection September 17, 2019 Reason for the Shortage

• Novartis had Arranon on shortage due to increased demand. Estimated Resupply Dates

• Novartis has Arranon 5 mg/mL 50 mL vials available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=458 Melphalan Tablets September 17, 2019 Reason for the Shortage

• Apo-Pharma did not provide a reason for the shortage. Estimated Resupply Dates






• Apo-Pharma has Alkeran 2 mg tablets on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=472 Levetiracetam Extended-Release Tablets September 17, 2019 Reason for the Shortage

• Lupin did not provide a reason for the shortage. • OWP is discontinuing their Roweepra XR formulations. • Sun Pharma did not provide a reason for the shortage. • Torrent is not selling their levetiracetam extended-release tablets within the US

Estimated Resupply Dates • Apotex has levetiracetam extended-release 500 mg and 750 mg tablets on back order and the

company estimates a release date in October 2019. • Lupin has levetiracetam extended-release 500 mg and 750 mg tablets on intermittent back order and

the company is shipping product as it becomes available. • Sun Pharma has levetiracetam extended-release 500 mg and 750 mg tablets on intermittent back

order and the company is shipping product as it becomes available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=583 Isocarboxazid Tablets September 17, 2019 Reason for the Shortage

• Validus has Marplan tablets on shortage due to manufacturing delays. They are in the process of transferring manufacturing sites in the US.

Estimated Resupply Dates • Validus has Marplan on long-term back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=411 Hypromellose Ophthalmic Solution September 17, 2019 Reason for the Shortage

• Akorn has Gonak on shortage due to lack of raw materials. • HUB Pharmaceuticals has Goniovisc available. • Altaire has Goniotaire on shortage due to a voluntary recall. • OcuSoft did not provide a reason for the shortage.

Estimated Resupply Dates • Akorn has Gonak 2.5% ophthalmic solution 15 mL bottles on allocation. • Altaire has Goniotaire 2.5% ophthalmic solution 15 mL bottles on back order and the company

cannot estimate a release date. • OCuSOFT has Goniosoft 2.5% ophthalmic solution on back order and the company cannot estimate a

release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=437






Hydroxyzine Pamoate Oral Capsules September 17, 2019 Reason for the Shortage

• Amneal did not provide a reason for the shortage. • Mylan discontinued hydroxyzine pamoate capsules in May 2019. • Pfizer did not provide a reason for the shortage. • Rising discontinued hydroxyzine pamoate capsules. • Sandoz has hydroxyzine pamoate capsules available. • Teva has hydroxyzine pamoate capsules available.

Estimated Resupply Dates • Amneal has hydroxyzine pamoate 25 mg capsules in 100 count bottles on intermittent back order

and the company is releasing product as it becomes available. • Pfizer has Vistaril 25 mg and 50 mg capsules in 100 count bottles on back order and the company

estimates a release date of October 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=545 Fluorescein Sodium Ophthalmic Strips September 17, 2019 Reason for the Shortage

• Hub has Bio-Glo available. • Akorn did not provide a reason for the shortage.

Estimated Resupply Dates • Akorn has Ful-Glo 0.6 mg and 1 mg strips on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=362. Erythromycin Ophthalmic Ointment September 17, 2019 Reason for the Shortage

• Akorn did not provide a reason for the shortage. • Bausch Health did not provide a reason for the shortage. • Perrigo has erythromycin ophthalmic ointment on shortage due to increased demand.

Estimated Resupply Dates • Perrigo has erythromycin 0.5% ophthalmic ointment in 1 gram tubes in 50 count on back order and

the company estimates a release date of early-October 2019. • Akorn has erythromycin 0.5% ophthalmic ointment in 1 gram tubes in 50 count on back order and

the company cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=540 Epinephrine Injection September 17, 2019 Reason for the Shortage

• Amphastar stopped distributing epinephrine 1 mg/mL 30 mL vials on May 10, 2017. They are continuing to supply 0.1 mg/mL 10 mL syringes. These are on shortage due to increased demand.

• Pfizer stopped distributing epinephrine 1 mg/mL presentations on May 10, 2017. • BPI has epinephrine 1 mg/mL 2 mL ampules available. • Par has Adrenalin 1 mg/mL 1 mL and 30 mL vials available.






• Amphastar has epinephrine 0.1 mg/mL 10 mL syringes on allocation. • Pfizer has epinephrine 0.1 mg/mL 10 mL LifeShield syringes on back order and the company

estimates a release date of October 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=313 Epinephrine Auto-Injectors September 17, 2019 Reason for the Shortage

• Amneal has discontinued Adrenaclick. Amneal acquired Impax in 2018. • Mylan refused to provide availability information. • Sandoz launched Symjepi in January 2019 and product is available. • Teva has FDA approval for generic epinephrine.

Estimated Resupply Dates • Amneal has epinephrine 0.15 mg/0.15 mL and 0.3 mg/0.3 mL auto-injectors on allocation. • Sandoz has Symjepi available with expiration dates of April 2020 and July 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=420 Dexamethasone Sodium Phosphate Injection September 17, 2019 Reason for the Shortage

• American Regent is not marketing dexamethasone sodium phosphate injection at this time. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi has dexamethasone sodium phosphate presentations available. • Mylan Institutional has dexamethasone injection available. • Hikma has dexamethasone injection on shortage due to increased demand. • Somerset Therapeutics has 10 mg/mL 1 mL vials available.

Estimated Resupply Dates • AuroMedics has dexamethasone sodium phosphate 4 mg/mL 1 mL and 30 mL vials on intermittent

back order and the company is releasing product as it becomes available. • Hikma has dexamethasone sodium phosphate 4 mg/mL 5 mL vials on back order and the company

estimates a release date of late-October to early-November 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=140 Azithromycin Injection September 17, 2019 Reason for the Shortage

• Apotex has discontinued azithromycin injection. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi had azithromycin injection on shortage due to increased demand. • Pfizer has azithromycin injection on shortage due to manufacturing delays. • Slate Run Pharmaceuticals has azithromycin injection available. • Sun Pharma is not currently manufacturing azithromycin injection.

Estimated Resupply Dates • AuroMedics has azithromycin 500 mg vials on intermittent back order and the company is releasing

product as it becomes available.





• Pfizer has azithromycin 500 mg ADD-Vantage vials on back order and the company estimates a release date of March 2020. Zithromax 500 mg vials are on back order and the company estimates a release date of November 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=380 Atropine Sulfate Injection September 17, 2019 Reason for the Shortage

• American Regent had atropine injection on shortage due to market demand. • Amphastar has atropine injection on shortage due to increased demand. • Fresenius Kabi has atropine injection available. • Hikma has atropine injection available. • Pfizer has atropine injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Fresenius Kabi has short-dated atropine 0.4 mg/mL 20 mL vials with an expiration date of <7 months. • Hikma has short-dated atropine 0.4 mg/mL 20 mL vials available with an expiration date of June

2020. • Pfizer has atropine 0.1 mg/mL 10 mL LifeShield syringes on back order and the company estimates

release dates of September 2019. The 0.1 mg/mL 10 mL Ansyr syringes are on back order and the company estimates a release date of December 2019. The 0.1 mg/mL 5 mL LifeShield syringes are on back order and the company estimates release dates of October 2019. The 0.05 mg/mL 5 mL Ansyr syringes are available with an expiration date of December 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=46 Amphetamine Mixed Salts, Immediate-Release Tablets September 17, 2019 Reason for the Shortage

• Aurobindo refuses to provide updated availability information. • Mallinckrodt has amphetamine mixed salts on allocation due to increased demand. • Sun Pharma discontinued amphetamine mixed salts in 2019. • Teva did not provide a reason for the shortage. • Zydus has amphetamine mixed salts available. • Mylan did not provide a reason for the shortage

Estimated Resupply Dates • Mallinckrodt has amphetamine mixed salts 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg immediate

release tablets on allocation and the company is releasing product as it becomes available. • Sun Pharma has discontinued all amphetamine mixed salts, immediate-release tablets. • TEVA has amphetamine mixed salts 10 mg tablets on back order and the company estimates a partial

release date of October 31, 2019. TEVA has amphetamine mixed salt 7.5 mg, 15 mg, 20 mg, and 30 mg tablets on back order and the company estimates a partial release date of early-October 2019.

• Mylan has amphetamine mixed salts 5 mg, 7.5 mg, 10 mg, 12.5mg, 15 mg, 20 mg, and 30 mg immediate release tablets on back order and the company estimates a resupply date of early-October 2019.






Amiodarone Injection September 17, 2019 Reason for the Shortage

• Baxter had Nexterone premixed bags on shortage due to manufacturing delays. • Mylan Institutional did not provide a reason for the shortage. • Hikma did not provide a reason for the shortage; however, the 50 mg/mL, 3 mL 10 count

presentation was discontinued in December 2018. • Sagent discontinued amiodarone 50 mg/mL 3 mL syringes in June 2019.

Estimated Resupply Dates • AuroMedics has amiodarone 50 mg/mL 3 mL, 9 mL, and 18 mL vials on intermittent back order and

the company is releasing product as it becomes available. • Hikma has amiodarone 50 mg/mL 3 mL vials on allocation. • Mylan Institutional has amiodarone 50 mg/mL 9 mL vials on back order and the company estimates a

release date of mid-November 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=374 5% Dextrose Injection (PVC-free and DEHP-free) September 17, 2019 Reason for the Shortage

• Baxter has 5% dextrose PVC/DEHP-free Viaflo bags available. • BBraun had 5% dextrose PVC/DEHP-free bags on shortage due to manufacturing delays. • BD has 5% dextrose PVC/DEHP-free bags available. • Fresenius Kabi has 5% dextrose PVC/DEHP-free bags available. • ICU Medical had 5% dextrose PVC/DEHP-free bags on shortage due to manufacturing delays.

Estimated Resupply Dates • Fresenius Kabi has 5% dextrose PVC/DEHP-free 500 mL bags available with short expiration dating (<

9 months). https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=314 0.9% Sodium Chloride Small Volume Bags (< 150 mL) September 17, 2019 Reason for the Shortage

• Baxter has 0.9% sodium chloride small volume bags available. • BBraun has 0.9% sodium chloride small volume bags available. • BD has 0.9% sodium chloride small volume bags available. • Fresenius Kabi has 0.9% sodium chloride small volume bags available. • ICU Medical did not provide a reason for the shortage. • Pfizer had 0.9% sodium chloride small volume presentations on shortage due to increased demand.

Estimated Resupply Dates • ICU Medical has 0.9% sodium chloride 50 mL and 100 mL VisIV bags on allocation to contracted

customers only. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=352 Tacrolimus Extended-Release Capsules and Tablets September 18, 2019 Reason for the Shortage

• Astellas has Astagraf XL capsules on allocation due to FDA guidance.




Estimated Resupply Dates • Astellas has Astagraf XL available on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=595 Tacrolimus Capsules September 18, 2019 Reason for the Shortage

• Accord has tacrolimus on allocation due to raw ingredient shortage. • Astellas has Prograf on allocation. • Bionpharma did not provide a reason for the shortage. • Lannett has discontinued tacrolimus capsules. • Major did not provide a reason for the shortage. • Mylan refuses to provide availability information. • Sandoz has tacrolimus available.

Estimated Resupply Dates • Accord has tacrolimus 0.5 mg, 1 mg, and 5 mg capsules on allocation. • Astellas has Prograf capsules on allocation. • Bionpharma has tacrolimus 0.5 mg, 1 mg, and 5 mg capsules on back order and the company cannot

estimate a release date. • Major has tacrolimus 0.5 mg, 1 mg, and 5 mg capsules on back order and the company cannot

estimate a release date. • Strides has tacrolimus 1 mg capsules on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=567 Hepatitis B Vaccine (Recombinant) September 18, 2019 Reason for the Shortage

• Merck has Recombivax HB on shortage due to increase in global demand. • GlaxoSmithKline has Engerix B products available. • GlaxoSmithKline discontinued Engerix B pediatric vials in October 2017.

Estimated Resupply Dates • Merck has Recombivax HB adult formulation vials and syringes on back order and the company

estimates this will continue through 2020. • Merck has Recombivax HB pediatric/adolescent formulation syringes and pediatric/adolescent

formulation vials in limited supply and this will continue through 2019. Merck's limited supply is being allocated to the CDC to ensure use is in accordance with their clinical guidance.

• Merck has Recombivax HB dialysis formulation 40 mcg/mL on back order and the company estimates this will continue through 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=320 Diphenhydramine Injection September 18, 2019 Reason for the Shortage

• Armas Pharmaceuticals has diphenhydramine injection available. • Fresenius Kabi has diphenhydramine injection available. • Hikma did not provide a reason for the shortage. • Mylan refuses to provide availability information.





• Pfizer has diphenhydramine injection on shortage due to manufacturing delays. Estimated Resupply Dates

• Pfizer has diphenhydramine 50 mg/mL 1 mL vials on back order and the company estimates a release date of August 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=456 Diclofenac Potassium Tablets September 18, 2019 Reason for the Shortage

• Mylan has diclofenac potassium tablets available. • Teva did not provide a reason for the shortage. • Sandoz discontinued diclofenac potassium tablets.

Estimated Resupply Dates • Teva has diclofenac potassium 50 mg tablets in 100 count and 500 count on back order and the

company estimates a release date of late-September 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=537 Ceftriaxone Sodium Injection September 18, 2019 Reason for the Shortage

• Apotex has ceftriaxone available. • Fresenius Kabi states the reason for the shortage was increased demand. • Hikma states the reason for the shortage is manufacturing delay. • Lupin has discontinued their ceftriaxone presentations. • Pfizer had ceftriaxone injection on shortage due to increased demand and manufacturing delays. • Piramal Critical Care has ceftriaxone injection available. • Sagent has ceftriaxone available. • Sandoz did not provide a reason for the shortage. • Wockhardt has discontinued their ceftriaxone presentations.

Estimated Resupply Dates • N/A

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=86 Cefepime Injection September 18, 2019 Reason for the Shortage

• Apotex has cefepime injection available. • Baxter has cefepime on allocation due to increased demand. • BBraun has cefepime on shortage due to manufacturing delays. • Fresenius Kabi has cefepime injection available. • Meitheal Pharmaceuticals has cefepime injection available • Pfizer has Maxipime on shortage due to manufacturing delays. • Piramal Critical Care has cefepime powder for solution for injection available. • Sagent has cefepime injection available. • Samson Medical Technologies has cefepime injection available. • Sandoz discontinued cefepime injection in early-2016.





• WG Critical Care has cefepime injection available. Estimated Resupply Dates

• Baxter has cefepime 2 gram premixed bags on allocation. • BBraun has cefepime 1 gram and 2 gram premixed bags on back order and the company cannot

estimate a release date. • Pfizer has Maxipime 1 gram and 2 gram vials and 1 gram and 2 gram ADD-Vantage vials on back

order and the company estimates a release date of August 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=59 Busulfan Injection September 18, 2019 Reason for the Shortage

• American Regent did not provide a reason for the shortage. • Amneal has busulfan injection available. • Apotex launched busulfan injection in August 2019. • Armas Pharmaceuticals launched busulfan injection in mid-2019. • Athenex launched busulfan injection in March 2019. • Mylan Institutional has busulfan injectable available. • Sagent has busulfan injection available. • Teva has busulfan injection available. • Otsuka has Busulfex available.

Estimated Resupply Dates • American Regent has busulfan 6 mg/mL 10 mL vials available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=509 Ampicillin Sodium and Sulbactam Sodium Injection September 18, 2019 Reason for the Shortage

• AuroMedics has ampicillin sulbactam vials on back order due to increased demand and manufacturing delays.

• Fresenius Kabi is not currently marketing ampicillin sulbactam injection. • Meitheal Pharmaceuticals did not provide a reason for the shortage. • Mylan Institutional refuses to provide availability information • Pfizer has discontinued generic ampicillin sulbactam except for the 1.5 gram and 3 gram ADD-

Vantage vials. • Sagent has ampicillin sulbactam vials on back order due to manufacturing delays and increased

demand. • Sandoz discontinued ampicillin sulbactam. • WG Critical Care states the shortage is due to increased demand.

Estimated Resupply Dates • AuroMedics has ampicillin sulbactam 3 gram and 15 gram vials on intermittent back order and the

company is releasing product as it becomes available. The 1.5 gram vials are on long-term back order and the company cannot estimate a release date.

• Hikma has ampicillin sulbactam 15 gram vials on back order and the company estimates a release date of mid- to late-January 2020. The 1.5 gram and 3 gram vials are on allocation.

• Meitheal Pharmaceuticals has all ampicillin sulbactam presentations on back order and the company estimates a release date of October 2019.




• Pfizer has Unasyn 1.5 gram vials available in limited supply. The 3 gram vials and 15 gram bulk vials are on back order and the company estimates a release date of December 2019. The 1.5 gram and 3 gram ADD-Vantage vials are on back order and the company estimates a release date of October 2019.

• Sagent has ampicillin sulbactam 1.5 gram vials and 15 gram bulk vials on back order and the company cannot estimate a release date. The 3 gram vials are on back order and the company estimates a release date of September 2019.

• WG Critical Care has ampicillin sulbactam 1.5 gram and 3 gram vials on back order and the company estimates a release date in mid- to late-September 2019. The 15 gram vials are on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=159 Tirofiban Hydrochloride Injection September 19, 2019 Reason for the Shortage

• Medicure Pharma has Aggrastat on shortage due to an interruption at their third-party manufacturing site.

Estimated Resupply Dates • Medicure Pharma has Aggrastat 5 mg/mL 100 mL premixed vials on back order and the company

estimates a release date of early-October 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=571 Penicillamine September 19, 2019 Reason for the Shortage

• Bausch Health did not provide a reason for the shortage. • Mylan did not provide a reason for the shortage.

Estimated Resupply Dates • Bausch Health has Cuprimine 250 mg capsules available. • Mylan has Depen 250 mg tablets available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=379 Leucovorin Calcium Injection September 19, 2019 Reason for the Shortage

• Fresenius Kabi had leucovorin on shortage due to manufacturing delays and increased demand. • Hikma did not provide a reason for the current shortage. • Mylan refuses to provide availability information. • Sagent has leucovorin on shortage due to manufacturing delays. • Teva has leucovorin available.

Estimated Resupply Dates • Fresenius Kabi has leucovorin 200 mg vials on back order and the company estimates a release date

of early- to mid-October 2019. Leucovorin 10 mg/mL 10 mL vials are on back order and the company estimates a release date of 4th quarter 2019.

• Hikma has leucovorin 50 mg, 100 mg, 200 mg, and 350 mg vials on allocation. • Sagent has leucovorin 50 mg, 100 mg, 200 mg, 350 mg, and 500 mg vials on allocation



Letermovir Injection September 19, 2019 Reason for the Shortage

• Merck has Prevymis on shortage due to a supply disruption. Estimated Resupply Dates

• Merck has Prevymis 20 mg/mL 12 mL vials on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=487 Labetalol Injection September 19, 2019 Reason for the Shortage

• Akorn did not provide a reason for the shortage. • Alvogen did not provide a reason for the shortage. • Fosun has labetalol injection available. • Hikma has labetalol injection on shortage due to increase demand. • Pfizer has labetalol injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Akorn has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company cannot estimate

a release date. • Hikma has labetalol 5 mg/mL 20 mL and 40 mL vials on allocation. • Pfizer has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company estimates a

release date of November 2019 for the 20 mL vials and January 2021 for the 40 mL vials. The 5 mg/mL 4 mL Carpuject syringes are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=286 Ketorolac Injection September 19, 2019 Reason for the Shortage

• Alvogen did not provide a reason for the shortage. • Amphastar did not provide a reason for the shortage. • Athenex has ketorolac available. • BD RX is now part of Fresenius Kabi. • Fresenius Kabi has most ketorolac presentations available. • Fosun Pharma has ketorolac available. • Pfizer has ketorolac injection on back order due to manufacturing delays. • Sagent states the reason for the shortage is manufacturing delay. • Hikma did not provide a reason for the shortage. • Ben Venue closed its plant in Bedford, Ohio in July 2014. • Virtus discontinued ketorolac in March 2019. • FDA imposed an import ban in mid-2013 on several Wockhardt products including ketorolac. • Sprix Nasal Spray is not affected by this shortage.

Estimated Resupply Dates • Alvogen has ketorolac 30 mg/mL 1 mL vials and 2 mL vials on back order and the company cannot

estimate a release date. • Amphastar has ketorolac 30 mg/mL 1 mL vials on back order and the company cannot estimate a

release date.


• Fresenius Kabi has ketorolac 15 mg/mL 1 mL prefilled syringes on back order and the company estimates a release date of 4th quarter 2019. The 30 mg/mL 1 mL vials are on back order and the company estimates a release date of mid-September 2019. The ketorolac 30 mg/mL 1 mL prefilled syringes are available with short expiry of < 5 months.

• Hikma has all ketorolac presentations on back order and the company estimates a release date of mid- to late-January 2020.

• Pfizer has ketorolac 15 mg/mL 1 mL vials on back order and the company estimates a release date of October 2019. The 30 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of March 2020. The 30 mg/mL 2 mL Carpuject syringes for intramuscular injection and 30 mg/mL 1 mL iSecure syringes are on back order and the company estimates a release date of August 2020.

• Sagent has ketorolac 15 mg/mL 1 mL vials, 30 mg/mL 1 mL vials, and 30 mg/mL 2 mL vials for intramuscular injection on back order and the company estimates a release date of October 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=113 Heparin Sodium Premixed Bags September 19, 2019 Reason for the Shortage

• Baxter has heparin premix available. • BBraun has heparin premixes available. • Fresenius Kabi has put heparin on a protective allocation due to a potential shortage of raw

ingredient. The letter describing this in detail is available at the following link: https://www.fresenius-kabi.com/us/news/fresenius-kabi-responds-to-a-potential-shortage-of-heparin.

• Pfizer has heparin on shortage due to manufacturing delays. Estimated Resupply Dates

• Pfizer has heparin 25,000 units/250 mL in 0.45% sodium chloride premixed bags on back order and the company estimates a release date of September 2019. All other premixed bags are available in limited supply.

• BBraun has all heparin premixed bags on intermittent back order and the company is releasing product as it becomes available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=468 Etomidate Injection September 19, 2019 Reason for the Shortage

• American Regent is not currently marketing etomidate. • Athenex did not provide a reason for the current shortage. • AuroMedics did not provide a reason for the current shortage. • Hikma has etomidate available. • Mylan Institutional has etomidate available. • Par Sterile Products discontinued etomidate in early 2015. • Pfizer has Amidate on shortage due to manufacturing delays. Pfizer discontinued etomidate ampules

in October 2016. • Sagent is no longer marketing etomidate. • Zydus did not provide a reason for the shortage.



• Athenex has etomidate 2 mg/mL 10 mL and 20 mL vials on back order and the company cannot estimate a release date.

• AuroMedics has etomidate 2 mg/mL 10 mL vials on intermittent back order and the company is releasing product as it becomes available.

• Pfizer has Amidate 2 mg/mL 10 mL and 20 mL vials on back order and the company estimates a release date of December 2019 for the 10 mL vials and October 2019 for the 20 mL vials. The 2 mg/mL 20 mL LifeShield syringes on back order and the company estimates a release date of March 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=147 Enalaprilat Injection September 19, 2019 Reason for the Shortage

• Hikma has enalaprilat injection on shortage due to increased demand. • Pfizer has enalaprilat injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Hikma has enalaprilat 1.25 mg/mL 1 mL on allocation. The 2 mL vials are on back order and the

company estimates a release date of early- to mid-December 2019. • Pfizer has enalaprilat 1.25 mg/mL 1 mL and 2 mL vials on back order and the company estimates a

release date of March 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=488 Dorzolamide Ophthalmic Solution September 19, 2019 Reason for the Shortage

• Akorn has dorzolamide ophthalmic solution on shortage due to manufacturing delays. • Merck did not provide a reason for the shortage. • Sandoz did not provide a reason for the shortage. • Teva discontinued dorzolamide ophthalmic solution in April 2018. • Bausch Health had dorzolamide ophthalmic solution on shortage due to manufacturing delays.

Estimated Resupply Dates • Akorn has dorzolamide 2% ophthalmic solution in 10 mL bottles on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=359 Dorzolamide 2% and Timolol 0.5% Ophthalmic Solution September 19, 2019 Reason for the Shortage

• Akorn has dorzolamide and timolol ophthalmic solution on shortage due to manufacturing delays. • Sandoz did not provide a reason for the shortage. • Teva discontinued dorzolamide and timolol ophthalmic solution in April 2018. • Bausch Health had dorzolamide and timolol ophthalmic solution on shortage due to manufacturing

delays Estimated Resupply Dates

• Akorn has Cosopt 2%/0.5% ophthalmic solution in 10 mL bottles on back order and the company cannot estimate a release date. The dorzolamide 2% and timolol 0.5% ophthalmic solution in 10 mL bottles are on allocation.



Deferoxamine Injection September 19, 2019 Reason for the Shortage

• Fresenius Kabi had deferoxamine on shortage due to increased demand. • Pfizer has deferoxamine on shortage due to manufacturing delays. • Novartis has Desferal available. • Alvogen did not provide a reason for the shortage. Alvogen launched deferoxamine injection in mid-

2018. • Apo-Pharma launched deferoxamine injection in mid-2018.

Estimated Resupply Dates • Alvogen has short-dated deferoxamine 500 mg and 2 gram vials available with an expiration date of

January 2020 for the 500 mg vials and June 2020 for the 2 gram vials. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=393 5% Lidocaine and 7.5% Dextrose Injection September 19, 2019 Reason for the Shortage

• Pfizer has 5% lidocaine and 7.5% dextrose 2 mL ampules on shortage due to manufacturing delays. • Pfizer is the sole supplier of this combination.

Estimated Resupply Dates • Pfizer has 5% lidocaine and 7.5% dextrose 2 mL ampules on long-term back order and the company

estimates a release date of March 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=253 Sodium Phosphate Injection September 20, 2019 Reason for the Shortage

• American Regent is not currently marketing sodium phosphate injection. • Fresenius Kabi has sodium phosphate injection available. • Pfizer has sodium phosphate injection on shortage due to manufacturing delay.

Estimated Resupply Dates • Pfizer has sodium phosphate 3 mmol/mL 15 mL vials on back order and the company estimates a

release date of March 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=227 Sodium Acetate Injection September 20, 2019 Reason for the Shortage

• American Regent is not currently marketing sodium acetate injection. • Fresenius Kabi has sodium acetate injection on back order due to increased demand. • Pfizer has sodium acetate injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Fresenius Kabi has sodium acetate 4 mEq/mL 100 mL vials on back order and the company estimates

a release date of early- to mid-October 2019. • Pfizer has sodium acetate 2 mEq/mL 20 mL vials are on intermittent stock out and the company

estimates a release date of September 2019. The 50 mL vials and 100 mL vials are on back order and


the company estimates a release date of October 2019 for the 50 mL vials and September 2019 for the 100 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=317 Ropivacaine Injection September 20, 2019 Reason for the Shortage

• Akorn has ropivacaine on shortage due to increased demand. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi has Naropin on shortage due to increased demand and manufacturing delays. • Pfizer had ropivacaine on shortage due to manufacturing delays. • Sagent has ropivacaine premixed bags available. • Somerset Therapeutics has ropivacaine 5 mg/mL 30 mL vials available.

Estimated Resupply Dates • Akorn has ropivacaine 5 mg/mL 30 mL vials on back order and the company cannot estimate a

release date. • AuroMedics has ropivcaine 10 mg/mL 10 mL and 20 mL vials and 2 mg/mL 100 mL bottles on

intermittent back order and the company is releasing product as it becomes available. • Fresenius Kabi has Naropin 5 mg/mL 30 mL Steripak ampules on back order and the company

estimates a release date of mid-October 2019. The 5 mg/mL 20 mL Steripak ampules are on back order and the company estimates a release date of late-September 2019. Check wholesalers for inventory.

• Pfizer has ropivacaine 2 mg/mL 10 mL and 20 mL vials on back order and the company estimates a release date of December 2019 for the 10 mL vials and November 2019 for the 20 mL vials. The 5 mg/mL 30 mL vials are on back order and the company estimates a release date of October 2019. The 7.5 mg/mL 20 mL vials are on back order and the company estimates a release date of December 2019. The 10 mg/mL 10 mL and 20 mL vials are on back order and the company estimates a release date of December 2019 for the 10 mL vials and October 2019 for the 20 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=384 Lidocaine with Epinephrine Injection September 20, 2019 Reason for the Shortage

• Fresenius Kabi has Xylocaine with epinephrine presentations on shortage due to increased demand for the product and manufacturing delays.

• Pfizer has lidocaine with epinephrine presentations on shortage due to manufacturing delays Estimated Resupply Dates

• Fresenius Kabi has 1% Xylocaine with epinephrine (1:200,000) 10 mL vials on back order and the company estimates release dates of late-September to early-October 2019. The 1% Xylocaine with epinephrine (1:200,000) 20 mL vials are on back order and the company estimates release dates of late-September to early-October 2019. The 1% Xylocaine with epinephrine (1:200,000) 50 mL vials are on back order and the company estimates release dates of early- to mid-October 2019. The 1% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials are on back order and the company estimates release dates of mid-October 2019. The 1% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot estimate a release date. The 1.5% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot estimate a release date. The 2% Xylocaine with epinephrine (1:200,000) 20 mL


vials are on back order and the company estimates a release date of early- to mid-October 2019. The 2% Xylocaine with epinephrine (1:200,000) 50 mL vials are on back order and the company estimates a release date of early- to mid-October 2019. The 2% Xylocaine-MPF with epinephrine (1:200,000) 20 mL vials in sterile packs are on back order and the company cannot estimate a release date. Check wholesalers for inventory.

• Pfizer has 0.5% lidocaine with epinephrine (1:100,000) 20 mL vials on back order and the company estimates a release date of September 2019. The 1% lidocaine with epinephrine (1:100,000) 50 mL vials are on back order and the company estimates a release date of October 2019. The 2% lidocaine with epinephrine (1:100,000) 30 mL vials are on back order and the company estimates a release date of November 2019. The 2% lidocaine with epinephrine (1:100,000) 50 mL vials are on back order and the company estimates a release date of September 2019. The 2% lidocaine with epinephrine (1:200,000) 20 mL vials are on back order and the company estimates a release date of September 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=98 Lidocaine Injection September 20, 2019 Reason for the Shortage

• Amphastar had lidocaine 2% emergency syringes available. • AuroMedics introduced lidocaine injection in February 2014. • Fresenius Kabi had generic lidocaine presentations on shortage due to a supply interruption of raw

ingredients. • Pfizer has lidocaine presentations on shortage due to manufacturing delays.

Estimated Resupply Dates • AuroMedics has 1% lidocaine 30 mL vials on intermittent back order and the company is releasing

product as it becomes available. AuroMedics has 2% lidocaine 5 mL vials on intermittent back order and the company is releasing product as it becomes available.

• Fresenius Kabi has 1% Xylocaine 50 mL vial on back order and the company estimates a release date of late-September to early-October 2019. The 1% Xylocaine-MPF 30 mL vial sterile packs are on back order and the company cannot estimate a release date. The 1.5% Xylocaine-MPF 20 mL ampules are on back order and the company estimates a release date of early- to mid-December 2019. The 2% Xylocaine-MPF 10 mL ampules are on back order and the company estimates a release date of early- to mid-December 2019. Check wholesalers for inventory.

• Hikma has 2% lidocaine 5 mL vials on back order and the company estimates a release date of late-September to early-October 2019.

• Pfizer has 1% lidocaine 5 mL preservative-free ampules on back order and the company estimates a release date of March 2020. The 1% lidocaine 30 mL preservative-free vials are on back order and the company estimates a release date of September 2019. The 1% lidocaine 5 mL Lifeshield syringes are on back order and the company estimates a release date of October 2019. The 1.5% lidocaine 20 mL preservative-free ampules are on back order and the company estimates a release date of February 2020. The 2% lidocaine 5 mL vials are on back order and the company estimates a release date of October 2019. The 2% lidocaine 5 mL Lifeshield syringes are on back order and the company estimates a release date of October 2019. The 2% lidocaine 5 mL Ansyr syringes are on back order and the company estimates a release date of December 2019.



Hydroxyprogesterone Caproate Injection September 20, 2019 Reason for the Shortage

• AMAG has Makena vials on shortage due to manufacturing delay. • American Regent has hydroxyprogesterone injection available. • AuroMedics has hydroxyprogesterone injection available. • Mylan has hydroxyprogesterone injection available. • Prasco discontinued the 5 mL vials in mid-2019. Prasco has hydroxyprogesterone 1 mL vials available. • Slayback Pharma has hydroxyprogesterone injection available.

Estimated Resupply Dates • AMAG has Makena 250 mg/mL 1 mL and 5 mL vials on back order and the company cannot estimate

a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=501 Bupivacaine with Epinephrine Injection September 20, 2019 Reason for the Shortage

• Fresenius Kabi has bupivacaine and epinephrine on shortage due to increased demand and manufacturing delays.

• Pfizer has bupivacaine with epinephrine on shortage due to manufacturing delays. Estimated Resupply Dates

• Fresenius Kabi has 0.25% Sensorcaine-MPF with epinephrine 10 mL vials on back order and the company estimates a release date of late-September to early-October 2019. The 0.25% Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of early- to mid-October 2019. The 0.25% Sensorcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of late-September to early-October 2019. The 0.5% Sensorcaine-MPF with epinephrine 10 mL vials are on back order and the company estimates a release date of early- to mid-October 2019. The 0.5% Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of late-September 2019. The 0.5% Sensorcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of late-September to early-October 2019. The 0.5% Sensorcaine-MPF with epinephrine 30 mL sterile packs are on back order and the company cannot estimate a release date.

• Pfizer has 0.25% bupivacaine with epinephrine 10 mL preservative-free vials on back order and the company estimates a release date of February 2020. The 0.25% bupivacaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of December 2019. The 0.25% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of December 2019. The 0.5% bupivacaine with epinephrine 10 mL preservative-free vials are on back order and the company estimates a release date of March 2020. The 0.5% bupivacaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of December 2019.The 0.5% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of January 2020.

• Pfizer has 0.25% Marcaine with epinephrine 10 mL preservative-free vials on back order and the company estimates a release date of October 2019. The 0.25% Marcaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of September 2019. The 0.25% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of October 2019. The 0.5% Marcaine with epinephrine 10 mL preservative-free vials are on back order and the company estimates a release date of January 2020. The 0.5%


Marcaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of June 2021.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=261 Testosterone Enanthate Intramuscular Injection September 23, 2019 Reason for the Shortage

• Hikma has testosterone enanthate available. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Teva has testosterone enanthate 200 mg/mL 5 mL vials temporarily unavailable with no estimated

release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=498 Secobarbital Capsules September 23, 2019 Reason for the Shortage

• Bausch Health is the sole supplier of secobarbital capsules. The company states that Seconal capsules are on back order due to a short-term stock out.

Estimated Resupply Dates • Bausch Health has Seconal (secobarbital) 100 mg capsules on back order and the company cannot

estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=517 Pentamidine Isethionate September 23, 2019 Reason for the Shortage

• Fresenius Kabi had Nebupent and Pentam 300 on back order due to a short-term manufacturer delay.

• Seton Pharmaceuticals has pentamidine isethionate injection on shortage due to high demand. Estimated Resupply Dates

• Seton Pharmaceuticals has pentamidine isethionate 300 mg vials for injection on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=584 Lorazepam Tablets September 23, 2019 Reason for the Shortage

• Aurobindo refuses to provide availability information. • Leading has all lorazepam tablet presentations on intermittent back order due to increased demand. • Major did not provide a reason for the shortage. • Mylan has discontinued all bottled presentations. • Mylan Institutional discontinued all unit-dose blister pack presentations. • Sandoz discontinued all lorazepam presentations. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Bausch Health has Ativan 1 mg tablets on back order and the company cannot estimate a release

date.


• Major has all lorazepam tablet presentations on back order and the company cannot estimate a release date.

• Leading has all lorazepam tablet presentations on intermittent back order and they are releasing product as it becomes available.

• Teva has lorazepam 0.5 mg tablets in 500 and 1,000 count and 1 mg tablets in 1,000 count on back order and the company estimates release dates of late-September to early-October 2019. The 1 mg tablets in 100 count are on back order and the company estimates release dates of mid-October 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=480 Hydroxyethyl Starch in Sodium Chloride Injection September 23, 2019 Reason for the Shortage

• BBraun did not provide a reason for the Hespan shortage. • Pfizer has 6% hetastarch in 0.9% sodium chloride injection available. • Pfizer has Voluven on back order. They did not provide a reason.

Estimated Resupply Dates • BBraun has Hespan on back order and the company cannot estimate a release date. • Pfizer has Voluven on back order and the company estimates a release date of August 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=454 Cosyntropin Injection September 23, 2019 Reason for the Shortage

• Amphastar has Cortrosyn on shortage due to increased demand. • Mylan Institutional did not provide a reason for the shortage. • Sandoz did not provide a reason for the shortage.

Estimated Resupply Dates • Mylan Institutional has cosyntropin 0.25 mg vials on back order and the company estimates a release

date of late-January 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=522 Betamethasone Acetate/Betamethasone Sodium Phosphate Suspension for Injection September 23, 2019 Reason for the Shortage

• American Regent had betamethasone acetate/betamethasone sodium phosphate on shortage due to minor shipping delays.

• Merck did not provide a reason for the shortage. • Exela Pharma Sciences has betamethasone acetate/betamethasone sodium phosphate on shortage

due to increased demand. Estimated Resupply Dates

• Exela has betamethasone acetate/betamethasone sodium phosphate 6 mg/mL 5 mL vials on intermittent back order and the company is releasing product as it becomes available.



BCG Live Intravesical September 23, 2019 Reason for the Shortage

• Because of increased global demand, and as the only source of BCG Live (Intravesical) in the United States and many other countries, Merck anticipates supply constraints for Tice BCG in 2019. To minimize disruption to patient care and address the current imbalance between supply and increased global demand, Tice BCG will be under allocation when demand exceeds production plans and available inventory.

Estimated Resupply Dates • Merck has Tice BCG on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=519 Metronidazole Hydrochloride Injection September 24, 2019 Reason for the Shortage

• Baxter did not provide a reason for the shortage. • BBraun has metronidazole injection available. • Pfizer has metronidazole injection available.

Estimated Resupply Dates • Baxter has metronidazole 100 mL bags (NDC 36000-0001-24) on back order and the company cannot

estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=316

*Please refer to ASHP website for more information at: https://www.ashp.org/Drug-Shortages/Current-Shortages

https://www.ashp.org/Drug-Shortages/Current-Shortages

https://www.ashp.org/Drug-Shortages/Current-Shortages

Drug Information Update · 2019. 9. 26. · lead to intraocular infections such as endophthalmitis...

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