Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches due to the potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch. There is a possibility that the application of a multi-stacked 25 mcg/h patch could result in serious, life threatening, or fatal respiratory depression. To date, Alvogen has received one serious adverse event related to this recall. The product is indicated for the management of severe and persistent pain in opioid-tolerant patients, that requires an extended treatment period with a daily opioid analgesic in opioid-tolerant patients, and for which alternative treatment options are inadequate. The impacted lot is Lot 108319 with an expiration date 04/2027.
