Ear Drops Recalled

Nearly 40,000 bottles of fluocinolone acetonide oil are being recalled by Glenmark Pharmaceuticals Inc. USA for failing to meet excipient specifications, according to the January 31, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects fluocinolone acetonide oil, 0.01% (ear drops), packaged in 1-ounce (20-mL) bottles (NDC 68462-185-56), from lots 05220346 and 05220369 (Exp. 1/31/24), 05220582 (Exp. 2/29/24), and 05220861 (Exp. 3/31/24). The drops were manufactured by Glenmark Pharmaceuticals Ltd., Himachal Pradesh, India, for Glenmark Pharmaceuticals Inc. USA, Mahwah, New Jersey, and were distributed throughout the United States.

Glenmark Pharmaceuticals voluntarily initiated the recall January 4, 2024. The FDA designated the recall Class II on January 22, 2024. Per the classification, use of the affected product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.

Fluocinolone acetonide oil is a prescription corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.