Fentanyl Transdermal System: Recall – Potential for Active Ingredient to Release Faster Than Specified
Fentanyl Pain Patch Recall Update 7/23/12: Healthcare giant Johnson & Johnson (J&J) is now recalling more than 53,000 Duragesic pain patches due to problems where crystals of fentanyl may have formed in some of the patches. Fentanyl is a potent painkiller approximately 100 times more powerful than morphine, and its accumulation into crystals in the patch has the potential to lead to overdoses and other adverse events.
October 22, 2010 – This week, the FDA notified healthcare professionals and patients that laboratory testing identified a patch that released its active ingredient faster than the approved specification. An accelerated release of Fentanyl can lead to adverse events for at-risk patients including (but not limited to):
- excessive sedation
- respiratory depression
- hypoventilation (slow breathing)
- apnea (temporary suspension of breathing)
What are Fentanyl Patches used to Treat?
The Fentanyl Transdermal System is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids. The product is manufactured for Actavis by Corium International in the United States.