WILMINGTON, Del. - Johnson & Johnson and Novartis AG's Sandoz unit recalled some patches containing the painkiller fentanyl, saying manufacturing defects may cause leaks that can lead to fatal overdoses.
The Duragesic patches, made by J&J's Alza Corp., may have a cut along the drug reservoir, exposing users directly to the fentanyl gel inside, the New Brunswick, N.J., company said in a statement. It's the third recall of some version of the patches since 2004.
"Perhaps the time has come for the FDA to order Johnson & Johnson to pull all versions of this product off the shelves," said Alex MacDonald, a Boston lawyer representing the families of former patch users. Juries have found that defective patches caused two deaths since lawsuits over the products began going to trial in 2006.
Yesterday's recall covers patches in the United States and Canada that release 25 micrograms of fentanyl in an hour, J&J said. The expiration dates are on or before December 2009.
Duragesic patches generated $1.16 billion in sales last year, according to Johnson & Johnson. Fentanyl is mostly used to treat cancer pain, according to the Food and Drug Administration.
The FDA issued a safety warning in December over the patches, saying improper use could cause breathing difficulties and death. That followed a July 2005 alert put out by the FDA after 120 patients taking the drug died.