FDA Drug recall D-0089-2024
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc
- FDA Drug
- Class III
- terminated
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class III recall of Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc by Taro Pharmaceuticals, citing failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone As….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0089-2024 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-11-06 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Taro Pharmaceuticals |
| Distribution | US |
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
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.
Identifiers
| ndc | 51672-3007-1 |
|---|---|
| code_info | Lot# AC86809, AC86812, Exp Date: 01/31/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0089-2024%22
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