Taro Pharmaceuticals Inc.: Drug Recall
Recall #D-0089-2024 · 11/06/2023
Class III: Low Risk
Recall Details
- Recall Number
- D-0089-2024
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Taro Pharmaceuticals Inc.
- Status
- Terminated
- Date Initiated
- 11/06/2023
- Location
- Brampton, Canada
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,196 bottles
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.
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
Distribution Pattern
Nationwide in the USA
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.