We recently reported about a $13 million verdict in Florida against the makers of the Fentanyl pain patch. Shortly thereafter, Ortho-McNeil-Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson, recalled two lots of its PriCara 50 mg/hr Duragesic pain patches. One of the lots was sold by PriCara and the other lot was sold by Sandoz, Inc., in the United States. Ortho-McNeil-Janseen announced that it was recalling the patches because the patches were defective and could expose the users to an excess of the fentanyl gel inside the patches. The result of the excess exposure could result in death or other serious injuries.
The company identified the defect, but said the problem has been corrected. The company said 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 CA, an affiliate of PriCara, manufactured the patches being recalled. The 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 the fentanyl gel.
Despite the claim of this being an isolated defect, this product has proven to be dangerous for some time. The companies which have manufactured and sold this product have had previous recalls of the product. In 2006, the FDA announced that Fentanyl pain patches could be used by those persons who experienced chronic pain and who had been taking pain medications for a long period of time. The patches are applied directly to the skin and are designed to release fentanyl, a strong opiate analgesic. The problems arise when the pain patches are cut or torn and release an excess amount of fentanyl into the blood stream. If you need more information on this subject contact Chad Cook in our firm at 800-898-2034.
Sources: FDA Web site and Johnson & Johnson Web site
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