Actavis has voluntarily recalled 14 lots of fentanyl transdermal system patches. The recalled patches may have a fold-over defect which can cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Direct exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible fatal overdose.
The lots being recalled include the 25mcg/hr, 50mcg/hr, 75mcg/hr, and 100mcg/hr dosage strengths and are labeled with an Abrika label on the patches and an Actavis logo on the outer carton.
For more information call (877) 422-7452 or visit www.fda.gov/medwatch/safety/2008/safety08.htm#Fentanyl.