Drug recall D-0089-2024
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
Reason for recall
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.
Lots and codes
Lot# AC86809, AC86812, Exp Date: 01/31/2024
Recall details
- Recalling firm
- Taro Pharmaceuticals Inc., Brampton
- Quantity
- 11,196 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 6, 2023
- Terminated
- August 27, 2024
Related products
- Hydrocortisone and acetic acid – drug information
- NDC 51672-3007 Hydrocortisone and Acetic Acid · Hydrocortisone 10.4 mg/mL; Acetic Acid 20.8 mg/mL · Sun Pharmaceutical Industries, Inc.