J&J Recalls Fentanyl Pain Patches for Crystallized Drug

July 20, 2012 — Johnson & Johnson is recalling 53,000 Duragesic pain patches after finding a lot that “exhibited white spots, which were determined to be small fentanyl crystals.” The company has issued a Class III recall.

There have been no reported injuries due to the defect, and it is unlikely to cause serious injury. Even so, this is not the first time J&J has recalled the pain patches due to manufacturing problems — other recalls were initiated after the patches were linked to life-threatening overdoses.

J&J is recalling the Duragesic 25 microgram-per-hour patches, which expire in March 2013. Wholesalers purchased the products between September and October 2011, and J&J says it is likely that most of the patches have already been used by customers.

Duragesic pain patches are a product that delivers a powerful painkiller through the skin. The patches contain Fentanyl, an opioid anesthetic, in gel form. When the patch is placed on the skin, Fentanyl is absorbed through the skin into the body. Most types of pain patches are used to treat pain for several days. J&J reported sales of the Duragesic pain patches topped $589 million in 2011.

In the past, problems with the Duragesic pain patches have sparked numerous public health warnings and injury lawsuits. In 2004 and 2008, the Duragesic pain patches were recalled because they could become damaged, potentially releasing large amounts of the drug. This could cause a deadly drug overdose. Caregivers of a patient could also be injured by the pain patches.

J&J has issued several product recalls recently, mostly over-the-counter products but also some medical devices and prescription drugs. Executives of the company recently agreed to a settlement with shareholders, who sued because executives failed to address ongoing safety, quality control, and manufacturing deficiencies.