Taro Pharmaceuticals Inc. recalls Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc.
Recalled November 15, 2023 · FDA recall D-0089-2024 · Taro Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing. · FDA Class III
Units
11,196 bottles
Sold at
Nationwide in the USA
Description
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Product
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1
Manufacturer(s)
Taro Pharmaceuticals Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →