Actavis Recalls All Fentanyl Transdermal System C II Patches Sold in the United States
Fentanyl Pain Patch Recall Update 7/23/12: Healthcare giant Johnson & Johnson (J&J) is now recalling more than 53,000 Duragesic pain patches due to problems where crystals of fentanyl may have formed in some of the patches. Fentanyl is a potent painkiller approximately 100 times more powerful than morphine, and its accumulation into crystals in the patch has the potential to lead to overdoses and other adverse events.
What’s the problem?
The latest Fentanyl patch recall is an expansion of the initial recall of 14 lots of Fentanyl transdermal patches announced on February 17, 2008, which was due to the identification of a possible fold-over defect present in the product. According to Actavis Inc., the new recall is being used as a precautionary measure to assure that all patches are safe from defects.
PriCara®, announced that one lot of 50 microgram/hour (mcg/hr) DURAGESIC® (fentanyl transdermal system) CII patches sold by PriCara in the United States and one lot of 50 mcg/hr fentanyl patches sold by Sandoz Inc. were being recalled. The recall is being conducted in coordination with the U.S. Food & Drug Administration (FDA).
ALZA Corporation of Mountain View, CA, an affiliate of PriCara, manufactured the patches being recalled. DURAGESIC 50 mcg/hr (fentanyl transdermal system) patches and Sandoz Inc. 50 mcg/hr fentanyl transdermal system patches being recalled may have a cut along one side of the drug reservoir.