Topical Corticosteroid Recalled

Citing out-of-specification assay results, Amneal Pharmaceuticals of New York is recalling two lots of fluocinolone acetonide solution, according to the November 24, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were distributed by Amneal Pharmaceuticals, Bridgewater, NJ, throughout the United States:

• fluocinolone acetonide 0.01% topical oil, body oil, packaged in 4-ounce bottles (NDC 65162-704-86), from lot 07040001A (Exp. 2/22); and
• fluocinolone acetonide 0.01% topical oil, scalp oil, packaged in 4-ounce bottles (NDC 65162-703-86), from lot 07030002A (Exp. 2/22).

Amneal Pharmaceuticals of New York voluntarily initiated the recall November 4, 2021. The FDA designated the recall Class II on November 16, 2021. The classification warns that use of the product may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Fluocinolone acetonide topical oil is a prescription corticosteroid used to treat eczema, dermatitis, and other skin conditions.