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53,000+ Duragesic Pain Patches Recalled by Johnson & Johnson

Jul 19, 2012 | Parker Waichman LLP

Johnson & Johnson has issued a new recall for more than 53,000 Duragesic Pain Patches, according to the company.  The recall was issued because of the discovery of small crystals of fentanyl on at least one patch in the recalled lot.

Duragesic and other fentanyl pain patches are used to provide long-lasting relief to cancer patients and others with moderate-to-severe chronic pain.  Fentanyl is a highly-potent opioid painkiller, and has a high potential for abuse and a risk for fatal overdose. 

According to Johnson & Johnson, the recall for the Duragesic Patches was issued at the wholesale level in April.  It involved a single lot of Duragesic 25 microgram-per-hour patches, with an expiration date of March 2013.  The recalled patches were shipped to wholesalers between September and October 2011.   The company says the patches do not pose any risks, and the U.S. Food & Drug Administration (FDA) has deemed the recall Class III.

This recall is just the most recent of several Johnson & Johnson has issued over the past several years for Duragesic pain patches.  Between 2004 and 2008, a number of Duragesic Pain Patch recalls were issued because of defects that could cause the patches to leak fentanyl gel that could come in direct contact with the skin of users or other people.  This can lead to deadly fentanyl overdoses.

In April, the FDA warned that there have been 26 cases of accidental exposure to fentanyl from pain patches since 1997, most of them involving children younger than 2 years old. There have been 10 deaths and an additional 12 cases requiring hospitalization.  

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