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news.PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals, has announced that one lot of 50mcg/hr Duragesic CII patches sold by PriCara in the US and one lot of 50mcg/hr fentanyl patches sold by Sandoz in the US are being voluntarily recalled as a precaution from wholesalers and pharmacies.
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The recall is being conducted in co-operation with the 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, California, an affiliate of PriCara, manufactured the patches being recalled.
Duragesic 50mcg/hr (fentanyl transdermal system) patches and Sandoz 50mcg/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, the company said.
As per the approved product labeling for Duragesic, fentanyl is a potent schedule II opioid medication.