July 20, 2012 — Johnson & Johnson has announced a Class III recall of more than 53,000 Duragesic pain patches. At least one lot was found to have small crystals of Fentanyl, which is the powerful anesthetic in the pain patches. The recall was initiated after J&J found one lot “exhibited white spots, which were determined to be small fentanyl crystals.” No adverse events have been reported, and the problem isn’t likely to cause serious injury — unlike other recalls of the product, which have been linked to deadly overdoses.
The products being recalled are the Duragesic 25 microgram-per-hour patches. They have an expiration date of March 2013. The products were sold between September and October 2011.
Duragesic is a brand of “pain patch,” with the powerful opioid anesthetic Fentanyl inside in gel-form. When the patch is placed on the skin, Fentanyl is absorbed through the skin and into the body, which can relieve chronic pain for a few days. Sales of the Duragesic pain patch were $589 million in 2011.
Health officials in the U.S. have issued several alerts about potential problems with the Duragesic pain patch. If the patches are not used properly, or if they break, the active ingredient could come in contact with the skin of a caregiver or the patient. There were major recalls of the Duragesic in 2004 and 2008 due to the risk that products could leak, causing severe, life-threatening drug overdose injuries.
The Duragesic pain patches have sparked numerous injury lawsuits, alleging that the products had manufacturing defects that caused serious injuries. The products carry a warning that people should not use pain patches that have been damaged.
This recall is the latest in dozens of product recalls from J&J in the last few years, mostly involving over-the-counter medicines but also some prescription drugs and medical devices. The company was recently sued by its own shareholders, who were angry at company executives for failing to address problems with safety and manufacturing that have persisted since the 1990s.