Topical Anesthetic Recalled

Citing deviations from Current Good Manufacturing Practice regulations, Teva Pharmaceuticals USA Inc is recalling 353,964 tubes of lidocaine 2.5% and prilocaine 2.5% cream. The recall is included in the May 4, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were manufactured by Teligent Pharma Inc, Buena, NJ, and distributed by Actavis Pharma Inc, Parsippany, NJ, throughout the United States:

• lidocaine 2.5% and prilocaine 2.5% cream, packaged in 5-g tubes (NDC 0591-2070-72), from lots 16291 (Exp. 1/24) and 16469 (Exp. 2/24); and
• lidocaine 2.5% and prilocaine 2.5% cream, packaged in 30-g tubes (NDC 0591-2070-30), from lots 16255 (Exp. 11/22); 16256 and 16412 (Exp. 2/24); 16257 and 16258 (Exp. 12/22); 16505 and 16506 (Exp. 3/24); and 16627, 16786, 16787, and 16820 (Exp. 4/24).

On April 15, 2022, Teva Pharmaceuticals voluntarily initiated the recall, which was designated Class II by the FDA on April 27, 2022. Drugs 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 and prilocaine creams are a prescription topical anesthetic used prior to medical procedures or injections.