D-0089-2024 Class III Terminated
FDA drug recall D-0089-2024 was initiated by Taro Pharmaceuticals Inc. on November 6, 2023 and is designated Class III. 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 s… The recall status is terminated (terminated August 27, 2024). Affected quantity: 11,196 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 15, 2023
- Initiation Date
- November 6, 2023
- Termination Date
- August 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,196 bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot# AC86809, AC86812, Exp Date: 01/31/2024