July 23, 2012 – 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. Since it first hit the market, the Duragesic patch has been plagued by manufacturing problems that have allowed gel to leak out and cause unintentional overdoses and even death.
What’s the problem?
According to an enforcement report issued last month by the U.S. Food & Drug Administration (FDA), J&J sent out letters to distributors about the problems with the Duragesic patch in April, but there was never an official announcement of the recall. The FDA has classified the action as a Class III recall, which means that the patches in question are unlikely to cause any adverse health effects. To date, no illnesses or serious injuries have been reported in connection with this recall.
The new recall involves 53,640 J&J Duragesic 25 mcg/h Fentanyl Transdermal System patches from lot 1103836P1. The patches have an NDC of 50458-091-05, and an expiration date of 3/2013. At least one patch from this lot has been found to contain small fentanyl crystals which could leak out and cause an accidental overdose.