Actavis has voluntarily recalled the wholesale and retail levels only of 18 lots of Fentanyl Transdermal System 25mcg/hour C-II patches in the US.
Corium, a third party supplier for Actavis, manufactured the recalled patches at its Grand Rapids, Michigan facility.
Fentanyl Transdermal System is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.
Actavis identified one lot of 25mcg/hour Fentanyl patch shipped to market that contained one patch that released its active ingredient faster than the approved specification in laboratory testing.
Actavis said that an accelerated release of Fentanyl from a 25mcg/hour patch can lead to adverse events for at-risk patients, including excessive sedation, respiratory depression, hypoventilation (slow breathing) and apnea (temporary suspension of breathing).
Under this recall, all wholesalers and retailers are being asked to return the product they have on hand or in stock.