Fentanyl Transdermal System Patch

07 May 2009

Products Affected - Description

Fentanyl Transdermal System

Reason for the Shortage

• Pricara recalled all lots of fentanyl 25 mcg/hour transdermal systems manufactured by Alza Corporation and distributed in the US by Janssen (Duragesic) and Sandoz (generic). The recall only affected the 25 mcg/hour patches with an expiration date on or before December 31, 2009.
• Actavis also recalled all strengths of their fentanyl patches in March, 2008.
• Watson's fentanyl patches were in limited supply due to supply and demand.
• Teva and Janssen could not provide a reason for the shortage of their products.

Estimated Resupply Dates

• Mylan has available all of their fentanyl transdermal patches including 12.5 mcg/hour (NDC 00378-9119-98), 25 mcg/hour (NDC 00378-9121-98), 50 mcg/hour (NDC 00378-9122-98), 75 mcg/hour (NDC 00378-9123-98) and 100 mcg/hour (NDC 00378-9124-98) strengths.
• Teva has available all of their fentanyl transdermal patches including 25 mcg/hour (NDC 00093-6900-45), 50 mcg/hour (NDC 00093-6901-45), 75 mcg/hour (NDC 00093-6902-45), and 100 mcg/hour (NDC 00093-6903-45) strengths.
• Watson has available all of their fentanyl transdermal patches including 25 mcg/hour (NDC 00591-3198-72), 50 mcg/hour (NDC 00591-3212-72), 75 mcg/hour (NDC 00591-3213-72), and 100 mcg/hour (NDC 00591-3214-72) strengths.
• Sandoz has all fentanyl transdermal patches available including 12.5 mcg/hour (NDC 00781-7109-55), 25 mcg/hour (NDC 00781-7111-55), 50 mcg/hour (NDC 00781-7112-55), 75 mcg/hour (NDC 00781-7113-55), and 100 mcg/hour (NDC 00781-7114-55) strengths.
• Janssen has Duragesic transdermal patches available in 12.5 mcg/hour (NDC 50458-0037-05), 25 mcg/hour (NDC 50458-0033-05), 50 mcg/hour (NDC 50458-0034-05), 75 mcg/hour (NDC 50458-0035-05), and 100 mcg/hour (NDC 50458-036-05) strengths.

Related Shortages

• Alfentanil Injection— Resolved
• Butorphanol Injection— Resolved
• Choline Magnesium Trisalicylate
• Codeine Phosphate Oral Solution— No Longer Available
• Diazepam Injection— Resolved
• Hydrocodone Tablets
• Hydromorphone Hydrochloride Injection
• Indomethacin Capsules— Resolved
• Meperidine— Resolved
• Meperidine / Promethazine— No Longer Available
• Methadone Hydrochloride Injection— Resolved
• Methadone Hydrochloride Tablets— Resolved
• Methadone Injection— Resolved
• Methadone Oral Tablets and Liquid— Resolved
• Morphine PCA Syringes— Resolved
• Morphine Sulfate— No Longer Available
• Morphine Sulfate: Extended-Release Products
• Morphine Sulfate: Oral Concentrated Solution
• Oxycodone Combinations Capsules and Tablets
• Oxycodone Extended-Release Tablets— Resolved
• Oxycodone Tablets, Capsules, and Solutions
• Pentazocine / Naloxone Tablets
• Remifentanil Hydrochloride— Resolved
• Sufentanil Injection— Resolved

Updated

May 7, 2009; April 8, 2009; February 25, 2009; January 29, 2009; December 15, 2008; November 18, 2008; November 7, 2008; October 27, 2008; September 24, 2008; August 22, 2008; July 22, 2008; June 25, 2008; June 10, 2008; May 5, 2008. University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.

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