D-0089-2024 Class III Terminated
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