MORRISTOWN, N.J. Actavis last week recalled 18 lots of its patches designed to treat persistent, moderate to severe chronic pain.
The drug maker said that its Fentanyl Transdermal System 25 mcg/hr C-II patches — manufactured for Actavis by Corium International in the United States — were recalled after Actavis identified one lot of 25 mcg/hr Fentanyl patches (control/lot # 30349) shipped to market that contained one patch that released its active ingredient faster than the approved specification in lab testing. An accelerated release of Fentanyl from a 25 mcg/hr patch can lead to adverse events for at-risk patients, including excessive sedation, respiratory depression, hypoventilation and apnea.
The patches are packaged individually and boxed in quantities of five patches per box, and were sold to wholesalers and at retail. The expiration dates for the patches ranged from December 2011 to April 2012.
Actavis said that it has posted detailed information on its website under the “Fentanyl Recall Information” link, and that the Food and Drug Administration is aware of the voluntary recall.