Multiple manufacturers recall leaky fentanyl patches

February 21, 2008

Transdermal fentanyl recalled by various manufacturers.

Actavis Inc. is recalling 14 lots of transdermal fentanyl due to a defect which may cause the patches to leak fentanyl gel outside the reservoir. No injuries have been reported; however, exposure to the gel could put patients and caregivers at risk for serious adverse events including respiratory depression and possible overdose. The affected Actavis recalling all 25 mcg/hr lots of Duragesic transdermal fentanyl systems and all lots of 25 mcg/hr fentanyl patches sold by Sandoz, Inc. for the same reason. The affected