Antifungal Gel Recalled

Tolmar Inc is recalling 1271 tubes of naftifine hydrochloride gel 1% because samples failed impurity/degradation specifications. The August 10, 2022, US Food and Drug Administration (FDA) Enforcement Report cited “out-of-specification test results obtained for unspecified impurity relative retention time.”

The recall affects the following products, which were manufactured by Tolmar, Fort Collins, CO, and distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ, to a single consignee in Kentucky:

• naftifine hydrochloride gel 1%, 40 g tube (NDC 0115-1510-63), from lots 12386A (Exp. 8/23) and 11800A (Exp. 9/22);
• naftifine hydrochloride gel 1%, 60 g tube (NDC 0115-1510-58), from lot 11940A (Exp. 12/22); and
• naftifine hydrochloride gel 1%, 90 g tube (NDC 0115-1510-48), from lots 12070A (Exp. 5/23) and 11801A (Exp. 9/22).

Tolmar voluntarily initiated the recall July 11, 2022. On August 1, 2022, the FDA designated the recall Class II, communicating use of the gel may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Naftifine hydrochloride is a prescription gel used to treat fungal skin infections, including ringworm and athlete’s foot.