J&J/Actavis recall US lots of fentanyl patches

US health care major Johnson & Johnson says that all US lots of 25mcg/hr Duragesic (fentanyl transdermal system), CII patches sold by PriCara, and all 25mcg/hr patches sold by Sandoz, are being voluntarily recalled from wholesalers and pharmacies as a precaution. The withdrawn lots all expire on or before December 2009, and all are made by Alza Corp, an affiliate of J&J's PriCara. All 25mcg/hr patches manufactured by Alza and sold in Canada are also being recalled.

In separate news, Icelandic generic drugmaker Actavis says that its US unit has recalled 14 lots of its fentanyl transdermal painkiller from wholesalers and pharmacies as a precaution. The patches were manufactured by Corium International, a contract manufacturer for Actavis, and sold nationwide by Actavis South Atlantic. The firm stressed that its fentanyl patches sold in Europe are not affected. According to the US Food and Drug Administration, the recalled lots may have a fold-over defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Although unaware of any injuries resulting from this issue, Actavis is withdrawing these lots. The agency noted on its web site that exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose.