Corticosteroid Lotion Recalled

Glenmark Pharmaceuticals Inc is recalling several lots of mometasone furoate topical solution because of defective containers, according to the July 13, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were manufactured by Glenmark Pharmaceuticals Limited, Himachal Pradesh, India, for Glenmark Pharmaceuticals, Mahwah, NJ, and distributed throughout the United States:

• mometasone furoate topical solution, 0.1% (lotion), 30 mL-bottle (NDC 68462-385-37), from lots 05201358 (Exp. 6/22), 05210287 and 05210288 (Exp. 1/23), 05211446 (Exp. 7/23), 05211704 and 05211714 (Exp. 8/23), and 05212217 (Exp. 10/23); and
• mometasone furoate topical solution, 0.1% (lotion), 60 mL-bottle (NDC 68462-385-02), from lots 05201358 (Exp. 6/22), 05210287, 05210288, and 05210424 (Exp. 1/23), 05210425 and 05210435 (Exp. 2/23), 05211427, 05211439, and 05211445 (Exp. 7/23), 05211723, 05211731, 05211850, and 05211864 (Exp. 8/23), and 05212226, 05212250, and 05212261 (Exp. 10/23).

Glenmark Pharmaceuticals voluntarily initiated the recall June 16, 2022. On July 1, 2022, the FDA designated the recall Class III. Under the recall classification, use of the affected product is not likely to cause harm.

Mometasone furoate topical solution is a prescription corticosteroid for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.