Duragesic Patch Recall-February 2008
New Jersey-- PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. announced that all lots of 25 microgram/hour (mcg/hr) DURAGESIC® (fentanyl transdermal system) CII patches sold by PriCara in the United States and all 25 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies.
The recalled pain patches all have expiration dates on or before December 2009. The recalled patches are manufactured by ALZA Corporation, an affiliate of PriCara. The recall is being conducted in cooperation with the U.S. Food and Drug Administration. All 25 mcg/hr fentanyl patches manufactured by ALZA and sold in Canada also are being recalled.
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The recalled Duragesic 25 mcg/hr patches and Sandoz Inc. 25 mcg/hr generic fentanyl patches may have a cut along one side of the drug reservoir within the patch. The possible leak of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged could expose patients or caregivers directly to fentanyl gel. Do you need a patch recall lawyer?
Duragesic, fentanyl is a potent Schedule II opioid medication. Pain patches that are cut or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious side effects of respiratory depression (stop breathing or coma) and possible overdose, which could be fatal.
Patients or caregivers who come in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only. Never use soap or lotion as this may cause the pain gel to penetrate faster. Immediately dispose of affected patches with cut edges 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. Patients may then be tempted to use multiple pain patches which could result in overdose.
The cut edge in affected patches can be seen upon opening the sealed foil pouch that holds the patch. WARNING: Affected patches should not be handled directly.
DUROGESIC™ patches sold in Europe, Latin America and Asia are not affected by this Duragesic pain patch recall.
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Have you or a loved one been the victim of the Duragesic patch recall? Good advice: Please consider seeking legal counsel to find out what your legal options are. The consult is free, confidential, and you are under no obligation to proceed.
