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news.PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals has reported that all lots of 25 microgram/hour Duragesic CII patches sold by PriCara and all 25mcg/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 recalled patches all have expiration dates on or before December 2009, and all are manufactured by Alza, an affiliate of PriCara. The recall is being conducted in cooperation with the FDA. All 25mcg/hr fentanyl patches manufactured by Alza and sold in Canada also are being recalled.
Duragesic 25mcg/hr (fentanyl transdermal system) and Sandoz 25mcg/hr fentanyl transdermal system patches being recalled may have a cut along one side of the drug reservoir within the patch. 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 labeling for Duragesic, fentanyl is a potent Schedule II opioid medication.