Watson Pain Patch Recall: Risk of Fatal Fentanyl Overdose from Leaks

A fentanyl patch recall has been issued by Watson Pharmaceuticals, Inc. for one lot of their generic 100 mcg/hr pain patches, as manufacturing problems could cause the patches to leak the powerful fentanyl gel contained inside, potentially causing an overdose, respiratory depression or death.

The Watson pain patch recall was announced on Friday, for 100 mcg/hr Fentanyl Transdermal System patches shipped in the United States between April 2, 2009 and May 20, 2009, with the Lot Number 145287A. The lot number is located on the box or the foil patch, and any pouches covered by this recall should not be handled directly.

The fentanyl pain patch is a generic version of the Duragesic patch, and is designed for use by patients suffering from severe, chronic pain. The patch is supposed to release fentanyl, a powerful opioid that is 100 times more potent than heroine, over an extended period of time. However, if the fentanyl gel leaks out of the patch and comes in direct contact with the skin, it could cause a fatal fentanyl overdose.

Similar manufacturing problems have resulted in a number of prior recalls and hundreds of fentanyl pain patch overdose deaths have been associated with different versions of the patch since it was first introduced by Johnson & Johnson in 1994.

At least six different fentanyl patch recalls have been issued by Johnson & Johnson and companies manufacturing generic versions of the patch, raising questions about whether the powerful painkiller can be safely made.

Last year, in August 2008, another Watson fentanyl patch recall was issued for 75 mcg/hr pain patches due to the same risk of leaks and overdose.

Dozens of pain patch wrongful death lawsuits have been filed against manufacturers of the fentanyl patches, alleging that defects caused too much of the gel to be delivered into the users bloodstream. Out of the first four cases to go to trial against Johnson & Johnson, the plaintiffs have been successful in each case, receiving verdicts that combine to exceed $36 million.