Alvogen, Inc. is voluntarily recalling two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches. A small number of cartons labeled 12 mcg/h Fentanyl Transdermal System patches contained 50 mcg/h patches. The 50 mcg/h patches that were included in cartons labeled 12 mcg/h are individually labeled as 50 mcg/h.
This transdermal system is manufactured by 3M Drug Delivery Systems, St. Paul, Minnesota.
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.