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25mcg/hr Duragesic® Patches Recalled
Update: February 21, 2008 Actavis Inc. announced a nationwide recall of certain lots of Fentanyl transdermal system CII Patches sold in the United States and labeled with an Abrika or Actavis label. The product may have a fold-over defect which can cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. The lots covered by this recall include doses of 25, 50, 75, and 100 mcg/hr and are listed in the firm's press release. PriCara™, a Division of Ortho-McNeil-Jansses Pharmaceutical, Inc. and the Food and Drug Administration have voluntarily recalled Duragesic® (transdermal fentanyl patches). It's important to note the recall only applies to 25mcg/hr Duragesic® patches manufactured by PriCara and Sandoz, with expiration dates on or before December 2009. Other generic versions and doses are not impacted by the recall. The products are being recalled due to the potential that they may have a cut along one side of the drug reservoir within the patch which could expose patients or caregivers directly to fentanyl gel, which could result in difficulty breathing and potentially fatal overdose. For information on returning patches manufactured by PriCara, please call 800-547-6446 or visit the Johnson & Johnson Web site at http://www.jnj.com/news/jnj_news/20080212_145928.htm For information on returning patches manufactured by Sandoz, please call 800-901-7236 |
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