Class III
Terminated
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
- Company
- Taro Pharmaceuticals Inc.
- Recall Initiated
- November 6, 2023
- Posted
- November 15, 2023
- Recall Number
- D-0089-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 11,196 bottles
- Firm Location
- Brampton, Canada
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
Nationwide in the USA
Lot / Code Info
Lot# AC86809, AC86812, Exp Date: 01/31/2024
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