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Risk of Fentanyl Overdose Prompts Another Duragesic Patch Recall

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Johnson & Johnson has issued it’s second recall of Duragesic Pain Patches in less than a year because of a manufacturing defect that could lead to fentanyl overdoses. The most recent Johnson & Johnson  patch recall involves one lot  of Duragesic 50 mcg/hr patches under the lot number 0817239 sold by  PriCara.  The recall also includes one lot  Sandoz Inc. 50 mcg/hr patches under the lot number 0816851.

PriCara is a division of Ortho-McNeil-Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson. ALZA Corporation of Mountain View, CA, an affiliate of PriCara, manufactured the patches being recalled.  A  press release issued by PriCara said that other strengths of the patches, including 12.5, 25, 75 and 100 mcg/hr, are not affected.

In the press release, the company said it had identified a condition in manufacturing equipment that resulted in a cut-system defect in a small number of affected patches in the lots being recalled.  The defect could result in a  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.  Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal, the release said.

Last February, Johnson & Johnson recalled another 32 million Duragesic Pain Patches for a similar defect.  At the time, the company estimated that about two out of every million patches could be defective.

The Duragesic and other similar pain patches are meant to treat persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age or older. Fentanyl is a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose.

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