Drug Safety Alerts

Fentanyl Transdermal System 12 mcg/h transdermal patches - Consumer-level Recall

04/21/2019

On April 21, 2019, the United States Food and Drug Administration (FDA) issued a notice regarding a consumer-level recall of Fentanyl Transdermal System 12 mcg/h transdermal patches NDC # 47781-0423-47 manufactured by Alvogen Inc. This recall was issued because a small number of cartons labeled 12 mcg/h Fentanyl Transdermal System patches contained 50 mcg/h patches.

This recall affects lot numbers 180060 exp. 05/2020 and 180073 exp. 06/2020.

The 50 mcg/h patches that were included in cartons labeled 12 mcg/h are individually labeled as 50 mcg/h. Application of a 50 mcg/h patch instead of a prescribed 12 mcg/h patch could result in serious, life threatening, or fatal respiratory depression. Groups at potential increased risk could include first time recipients of such patches, children, and the elderly. To date, Alvogen Inc. has not received any reports of adverse events related to this issue.

CVS Caremark Response: This product is not carried by CVS Caremark Mail Service Pharmacy.

For more information about this recall, please call Alvogen Inc. toll-free at 1-866-770-3024 or visit www.alvogen.com. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.