J&J Recalls Two Pain Patch Lots, Identifies Root Cause

Two lots of Johnson & Johnson’s (J&J) fentanyl transdermal patches were recalled last month because the products might have a cut along the one side of the drug reservoir, which would cause them to leak and could expose patients to dangerously high amounts of the narcotic.

“The company has identified a condition in the manufacturing equipment that has since been corrected,” J&J says. “The condition resulted in a cut-system defect in a small number of affected patches in the lots being recalled.”

J&J said that a minor repair completed last month corrected the problem, and only one manufacturing line was affected. Of the six patches the company estimates are defective, three have already been returned to the manufacturer.
Drug GMP Report