It's a new blow for the controversial painkiller fentanyl. Johnson & Johnson and Sandoz are recalling defective fentanyl patches that could cause patients or caregivers to overdose. The recall follows a December FDA warning that misuse can cause overdose, and another in July 2005 that instructed patients to follow package instructions strictly to avoid overdosing.
Some of the patches may have a cut in the drug reservoir that could leak potent opioid gel. Exposure to it can lead to respiratory depression and overdose, J&J said in a statement. About 32 million of the patches will be recalled. The FDA says it's investigating.