Visual Guide - Florida Academy of Pain Medicine

Visual Guide

1©Endo Pharmaceuticals. All rights Reserved. January 2012 www.endo.com 1-800-462-ENDO (3636)

Strength NDC Tablet Image Color Shape Imprint

Opana ER 5 mg 63481-907-70 Pink Octagon 5

Opana ER 10 mg 63481-674-70 Light

Orange Octagon 10

Opana ER 20 mg 63481-617-70 Light

Green Octagon 20

Opana ER 30 mg 63481-571-70 Red Octagon 30

Opana ER 40 mg 63481-693-70 Yellow Octagon 40

Endo’s primary concerns are the health, well-being, and continuity of care for patients. For patients currently prescribed any of the following products, a visual guide has been provided to verify identity of these products.

Please refer to the product name of your prescription in the visual guide below to confirm the tablets in your prescription match the tablet images provided.

OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets CII

40 mg20 mg

15 mg

30 mg

5 mg 10 mg7.5 mg

NOTE: Tablets shown not actual size.

40 mg20 mg

15 mg

30 mg

5 mg 10 mg7.5 mg

40 mg20 mg

15 mg

30 mg

5 mg 10 mg7.5 mg

40 mg20 mg

15 mg

30 mg

5 mg 10 mg7.5 mg

40 mg20 mg

15 mg

30 mg

5 mg 10 mg7.5 mg



Opana 5 mg 63481-612-70 Blue Round E 612

5

Opana 10 mg 63481-613-70 Red Round E 613

10

OPANA® (oxymorphone hydrochloride) Tablets CII


Oxymorphone 5 mg 60951-794-70 Blue Round E 794

5

Oxymorphone 10 mg 60951-795-70 Red Round E 795

10

Oxymorphone Hydrochloride Tablets CII





Percocet 2.5/325 mg 63481-627-70 Pink Oval PERCOCET

2.5

Percocet 5/325 mg

63481-623-75

63481-623-70

63481-623-85

Blue Round PERCOCET5

Percocet 7.5/325 mg 63481-628-70 Peach Oval PERCOCET

7.5/325

Percocet 7.5/500 mg 63481-621-70 Peach Capsule

ShapedPERCOCET

7.5

Percocet 10/650 mg 63481-622-70 Yellow Oval PERCOCET

10

Percocet 10/325 mg 63481-629-70 Yellow Capsule

ShapedPERCOCET

10/325

PERCOCET® (oxycodone hydrochloride and acetaminophen, USP) Tablets CII



Percodan Tabs 63481-121-70 Yellow Round PERCODAN

PERCODAN® (oxycodone hydrochloride and aspirin, USP) Tablets CII



Endocet 7.5/500 mg 60951-796-70 Peach Capsule

ShapedE 796

7.5

Endocet 7.5/325 mg 60951-700-70 Peach Oval E 700

7.5/325

Endocet 10/650 mg 60951-797-70 Yellow Oval E 797

10

Endocet 10/325 mg 60951-712-70 Yellow Capsule

ShapedE 712

10/325

Endocet 5/325 mg

Endocet 5/325 mg

60951-602-70

60951-602-85White Round Endo

602

ENDOCET® (oxycodone hydrochloride and acetaminophen, USP) Tablets CII



Endodan Tabs 60951-310-70 Yellow Round Endo610

ENDODAN® (oxycodone hydrochloride and aspirin, USP) Tablets CII



Morphine 15 mg 60951-652-70 Blue Round E 652

15

Morphine 30 mg 60951-653-70 Green Round E 653

30

Morphine 60 mg 60951-655-70 Orange Capsule

ShapedE 655

60

Morphine 100 mg 60951-658-70 Blue Capsule

ShapedE 658100

Morphine 200 mg 60951-659-70 Green Oval E 659

200

Morphine Sulfate Extended-Release Tablets CII



Zydone 5/400 mg 63481-668-70 Yellow Elongated

OctagonalE5

Zydone 7.5/400 mg 63481-669-70 Blue Elongated

OctagonalE

7.5

Zydone 10/400 mg 63481-698-70 Red Elongated

OctagonalE

10


ZYDONE® (hydrocodone bitartrate/acetaminophen tablets, USP) CIII

Letter Regarding Potential Endo Product Supply Disruption and Possibility of Rare Tablet Mix-Up

January 9, 2012

Dear Healthcare Professional,

The intent of this letter is to provide you with advance notice of a potential short-term disruption in our supply of the

following products:










As a brief background, production of these products has been temporarily suspended by our contract manufacturer in

order for the manufacturer to implement manufacturing process improvements. These improvements are intended to

address rare instances of errors in the packaging of the tablets, potentially resulting in product mix-ups. Endo is aware of

only three product mix-ups with respect to these products since 2009, of which all three were detected by pharmacists. We

are not aware of any patient having experienced a confirmed product mix-up and there have been no adverse events

attributable to a product mix-up. We believe the likelihood of product mix-up reaching a patient is remote.

As a result of the implementation of these improvements, we anticipate that there may be a short-term disruption in the

supply of these products to your patients. This temporary supply disruption is not related to the efficacy or safety of

these products.

Endo’s principal concern is the health, well-being, and the continuity of care for patients. In order to minimize the impact

of this manufacturing issue on your patients and to ensure your patients are taking only the product you have prescribed

for them, we recommend that you take the following steps:

As a precautionary measure and as part of good health practice, ask your patients to confirm that all tablets in

their current prescription of any Endo product listed above look alike. Please refer your patients to the visual

guide found on www.endo.com so that they can see whether they have the correct medication. A copy of this

visual guide is enclosed for your use. If your patient does identify mixed-up tablets, they should promptly

consult with you or their pharmacist. Pharmacists have been informed of this issue and are being asked to review

tablets as they prepare all new prescriptions of the Endo products listed above.

In the case of Opana ER, temporarily refrain from starting new patients as there is no therapeutically equivalent

or pharmaceutically alternative substitutable product available. This will enable there to be adequate product

available for patients currently on Opana ER to remain on the drug.

We are working closely with the U.S. Food and Drug Administration (FDA) and the manufacturing facility to minimize

patient disruptions and our manufacturer plans to restart production of these products shortly. We will provide you with

an update on the supply status and any new developments as soon as possible. Please contact your Endo sales

representative should you have any additional questions or Endo customer service at 1-800-462-3636.

Sincerely,

Diane K. Jorkasky, MD

Senior Vice President Clinical Development and Chief Medical Officer

http://www.endo.com/

Important News Regarding Your Medication

January 9, 2012

Dear Patient,

If you are currently taking any of the following medicines, please read this important information:










Because of potential packaging issues at the manufacturing facility, there is a rare possibility that a wrong

tablet may be in your bottle.

Endo is aware of only three product mix-ups with respect to these products since 2009, of which all three

were detected by pharmacists. We are not aware of any patient having experienced a confirmed product

mix-up and there have been no adverse events attributable to a product mix-up. We believe the

likelihood of product mix-up reaching a patient is remote.

As a precautionary measure, we recommend that you:

Look at Your Medicine: We are asking you to look carefully at the tablets in your medicine bottle to make

sure they all look the same.

Check Your Tablets: If you are not sure how the tablets should look, please refer to the visual guide

attached to this letter or visit www.endo.com and check your tablets against the pictures provided. If all the

tablets in your bottle look exactly the same, you should continue to take your medication as directed by

your health care professional.

Talk to Your Pharmacist: If you discover that any of the tablets in your bottle are a different color or shape

from the others, you should promptly take the medicine back to your pharmacy so the pharmacist can

review the contents. Your pharmacist will be able to assist you.

Please contact Endo Customer Service at 1-800-462-3636 if you have any additional questions or concerns.

Sincerely,

Diane K. Jorkasky, M.D., FACP

Senior Vice President Clinical Development and Chief Medical Officer

Visual Guide - Florida Academy of Pain Medicine

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