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Medication Recall: Two lots of fentanyl transdermal system (patch) recalled

by Mary McNitt | Apr 25, 2019

The U.S. Food and Drug Administration (FDA) announced that Alvogen, Inc. voluntarily recalled two lots of fentanyl patches 12 mcg/hour at the consumer level. Fentanyl patches (generic for Duragesic®) are commonly used to manage chronic pain which is severe enough to require daily, around-the-clock treatment with a long-acting opioid analgesic.  

Reason for recall
The two lots are being recalled due to product mislabeling in which a small number of cartons contained 50 mcg/hour patches rather than 12 mcg/hour patches. If the higher strength is applied to the skin, this could result in serious, life-threatening or fatal respiratory depression. To date, the company has not received any reports of any adverse events related to this mislabeling issue.  

The following lots, distributed nationwide to pharmacies, are included in this recall:

NDC number Lot Number Expiration date Strength
47781-423-47 (5-pack carton) 180060 05/2020 12 mcg/hour
47781-423-47 (5-pack carton) 180073 06/2020 12 mcg/hour

 

Alvogen is notifying its distributors and direct customers by letter to arrange for the return and replacement of all recalled products. Pharmacies should not dispense these products to consumers.

Impact on workers’ compensation
There has been a minimal impact in our book of business. If fentanyl patches 12 mcg/hour were dispensed in the original box from the manufacturer, claimants may be able to identify if they received a recalled product by checking the lot number and expiration date. According to the FDA, claimants affected by this recall should immediately remove any patch currently in use, contact their prescriber and return any unused product to the dispensing pharmacy. Because there are a number of other generic manufacturers that distribute fentanyl patches 12 mcg/hour, pharmacies should be able to replace the recalled lot with another product.  

For more information on this recall and contact information for Alvogen, please click here.  

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Source:
U.S. Food and Drug Administration. Safety/Recalls, Market Withdrawals & Safety Alerts. Company Announcement. Alvogen Inc. Issues Voluntary Nationwide Recall of Fentanyl Transdermal System Due to Product Mislabeling. April 19, 2019. Available at: https://www.fda.gov/Safety/Recalls/ucm636384.htm.


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