PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, stated 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 in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies. The recall is being conducted in cooperation with the US Food and Drug Administration (FDA).
The company has identified a condition in the manufacturing equipment that has since been corrected. The condition resulted in a cut-system defect in a small number of affected patches in the lots being recalled. ALZA Corporation of Mountain View CA, an affiliate of PriCara, manufactured the patches being recalled. Duragesic 50 mcg/hr patches and Sandoz Inc 50 mcg/hr fentanyl transdermal system patches being recalled may have a cut along one side of the drug reservoir. The result is possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel.
As per the approved product labelling for Duragesic, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are cut or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly wash exposed skin with large amounts of water only; do not use soap, alcohol, lotions, oils or other products to remove the medicine gel because they may increase the medicine's ability to go through the skin.
Immediately patches with cut edges should be disposed by flushing them down the toilet, using caution not to handle them directly. Patches with a cut edge that have leaked gel will not provide effective pain relief.