Taro Pharmaceuticals U.S.A., Inc. recalls Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton,…

Recall date

August 7, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0633-2024

FDA classification

Class III

Brand / firm

Taro Pharmaceuticals U.S.A., Inc.

Sold / distributed

Product was distributed to one distributor

Why it was recalled

Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01