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Fentanyl Patch Defect



A fentanyl leak from a Duragesic dermal patch can cause severe respiratory distress or even a fatality. For this reason, millions of Duragesic patches have been recalled.

What’s the problem?

The latest Fentanyl patch defect issue has resulted in the February 2008 recall of dermal patches by Johnson & Johnson. Fentanyl patches have been the subject of numerous recalls since they were first released to the public. The internal reservoir that holds the gel-form fentanyl in the patch is defective with a cut that lets the fentanyl leak out. Direct contact with fentanyl, which is a schedule II narcotic 80 times stronger than morphine, can cause severe breathing difficulties and even death.

Hundreds of people in the U.S. have died from fentanyl overdoses, and J&J is facing more than 70 Duragesic lawsuits based on fentanyl patch defects. The U.S. FDA has issued numerous warnings and alerts about Duragesic patches, which are sold by PriCara, a unit of Johnson & Johnson, and by Sandoz, a unit of the pharmaceutical company Novartis. Duragesic patches with a December 2009 or earlier expiration date, sold in the U.S. and Canada, are the subject of the latest recall.

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