October 04, 2019
Akorn “reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product,” according to the October 2, 2019, US Food and Drug Administration (FDA) Enforcement Report. “No particulates were identified in the product, but rather were identified on the filling line.”
The recall affects 30-mL tubes of lidocaine hydrochloride jelly, 2% (NDC 17478-711-30), from lot 9B21A (Exp. 1/22). The affected tubes were distributed throughout the United States and Puerto Rico.
Akorn voluntarily initiated the recall September 17, 2019. The FDA designated the recall Class II on September 24, 2019. The classification suggests use of the product could cause temporary or medically reversible adverse health consequences. Although the likelihood is remote, a possibility of serious harm also exists.
Lidocaine hydrochloride jelly, 2%, is a prescription local anesthetic agent used to control pain in procedures involving the urethra, to treat painful urethritis, or as an anesthetic lubricant for endotracheal intubation.