FDA ADVISORY - FEBRUARY 15, 2008


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FDA ADVISORY - FEBRUARY 15, 2008

Sat, February 16, 2008

Duragesic 25 mcg/hr (fentanyl transdermal system) CII Pain Patches: Audience: Pain management specialists, other healthcare professionals, patients [Posted 02/15/2008] PriCara and Sandoz Inc. announced a nationwide recall of all lots of 25 mcg/hr Duragesic Patches sold in the United States. The product is being recalled because the patches may have a cut along one side of the drug reservoir within the patch which may result in the possible release of fentanyl gel that may expose patients or caregivers directly to fentanyl gel on the skin. Fentanyl is a potent Schedule II opioid medication and exposure to the gel may lead to serious adverse events, including respiratory depression and possible overdose, that may be fatal. Patches with a cut edge should not be used. These recalled patches have expiration dates on or before December 2009 and are all manufactured by ALZA Corporation.