Patches containing the painkiller fentanyl have been recalled because they may contain manufacturer defects that can cause leaks, which can lead to overdoses and death. The Duragesic patches, made by Johnson & Johnson’s Alza Corp., may have a cut along the drug reservoir, exposing users directly to the fentanyl gel inside, the New Brunswick, New Jersey-based company said in a statement. Fentanyl is mostly used to treat cancer pain. Duragesic patches contain fentanyl in a pouch between two membranes.
The recall covers patches in the U.S. and Canada that release 25 micrograms of fentanyl in an hour, Johnson & Johnson said. The expiration dates are on or before December 2009.

The company has been plagued by problems with versions of these patches since their creation in 1994. Manufacturing problems also caused recalls of versions of these patches in 1994, 1996, and 2004.
In July 2005 The U.S. Food and Drug Administration issued an alert about the patches after 120 patients taking the drug died. The FDA issued safety warning in December over the patches, saying improper use can cause breathing difficulties and death. Johnson & Johnson said in November that it faced 72 lawsuits over the patches.

Texas and Florida juries found that defective patches caused the deaths of Michaelynn Thompson and Adam Hendelson. A Texas state court jury awarded Thompson’s family more than $772,000 in damages, and a federal jury in Florida ordered the company to pay Hendelson’s family $5.5 million.