Anesthetic Lotion Recalled

McKesson Corporation, doing business as McKesson Drug Company, is recalling nearly 82,000 bottles of lidocaine hydrochloride topical solution 4%. According to the May 11, 2022, US Food and Drug Administration (FDA) Enforcement Report, “all products within expiry are being recalled because the manufacturing firm, Teligent Pharma Inc, is discontinuing its stability study program.”

The recall affects 50-mL bottles of lidocaine hydrochloride topical solution 4%, 40 mg/mL (NDC 63739-977-64), from lots 15597 (Exp. 5/31/23), 16305 (Exp. 12/23/23), 16334 (Exp. 1/31/24), 16340 (Exp. 1/31/24), 16346 (Exp. 1/31/24), 16356 (Exp. 1/31/24), and 16357 (Exp. 1/31/24).

The recalled product was manufactured by Teligent Pharma Inc, Buena, NJ, and distributed by McKesson Corporation, doing business as Sky Packaging, Memphis, TN, throughout the United States, including Guam and the Northern Mariana Islands.

McKesson voluntarily initiated the recall April 21, 2022. The FDA designated the recall Class II on May 5, 2022. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Lidocaine hydrochloride topical solution 4% is a prescription lotion indicated for topical anesthesia of mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract.