Duragesic Pain Patch
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Multiple lots of 25 microgram/hour (mcg/hr) DURAGESIC® Fentanyl Transdermal System CII Patches that were sold by PriCara in the United States have been recalled. These 25 mcg/hr fentanyl patches were sold by Sandoz Inc. in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies. The recalled patches all have expiration dates on or before December 2009, and all are manufactured by ALZA Corporation, an affiliate of PriCara.
This Duragesic Pain Patch 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.
The DURAGESIC 25 mcg/hr (fentanyl transdermal system) and the Sandoz Inc. 25 mcg/hr fentanyl transdermal system patches were recalled for there maybe a cut or defect along one side of the drug reservoir within the patch. The result of this defect can cause the improper 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. 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.
Individuals that come in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. 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. These defective patches can be dangerous and even deadly.
Anyone who has 25 mcg/hr DURAGESIC or Sandoz Inc. fentanyl patches should check the box or foil pouch for the expiration date to determine if the patches are being recalled. The recalled patches that have expiration dates on or before December 2009.
It is important to understand that the defective recalled patches with the cut edge in affected patches can be seen upon opening the sealed foil pouch that holds the patch. Affected patches should not be handled directly.
Anyone with 25 mcg/hr DURAGESIC patches being recalled should call 800-547-6446.
Anyone with 25 mcg/hr Sandoz Inc. patches being recalled should call 800-901-7236.
Patients using fentanyl patches who have medical questions should contact their health-care providers.
If you or someone you know have been injured or affected by a Duragesic Pain Patch, call the Carabin & Shaw Law Firm, P.C. at (210) 222-2288 or 1-800-862-1260. We are available to discuss the matter for free, a no cost and no obligation consultation.
TRADEMARK NOTICE: Duragesic is a trademark of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
The Carabin & Shaw Law Firm, its' lawyers and this website is in no way affiliated with Ortho-McNeil-Janssen Pharmaceuticals, Inc. The use of this mark is solely for informational and product identification purposes.
