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, O
Recalled August 21, 2024 · FDA recall D-0633-2024 · Taro Pharmaceuticals U.S.A
Hazard
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. · FDA Class III
Units
96 vials
Sold at
Product was distributed to one distributor
Description
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.
Product
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
Manufacturer(s)
Taro Pharmaceuticals U.S.A., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →