Ear Infection Drug Recalled

Taro Pharmaceuticals USA Inc. is recalling 96 vials of hydrocortisone and acetic acid otic solution for failing to meet impurity and degradation specifications. The August 21, 2024, US Food and Drug Administration (FDA) Enforcement Report cited “out-of-specification results obtained for related impurities and slightly lower than the established level of the hydrocortisone assay obtained during stability testing.”

The recall affects hydrocortisone 1% and acetic acid 2% otic solution in 10-mL bottles (NDC 51672-3007-01) from lot AD12890 (Exp. 9/30/24). The drug was manufactured by Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, and was distributed by Taro Pharmaceuticals USA, Hawthorne, New York.

Taro Pharmaceuticals USA voluntarily initiated the recall on August 7, 2024. The FDA designated the recall Class III on August 13, 2024. Per the classification, use of the affected solution is not likely to cause harm.

Hydrocortisone and acetic acid otic solution is a prescription drug indicated for the treatment of superficial infections of the external auditory canal.