FDA Drug recall D-0633-2024
Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T…
- FDA Drug
- Class III
- completed
- Published 2024-08-21
On 2024-08-21 the FDA classified a Class III recall of Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T… by Taro Pharmaceuticals U, citing failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assa….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0633-2024 |
| Classification | Class III |
| Status | completed |
| Initiated | 2024-08-07 |
| Published | 2024-08-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Taro Pharmaceuticals U |
| Distribution | n/a |
Product
Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01
Reason
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Identifiers
| code_info | Lot # AD12890, Exp 09/30/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0633-2024%22
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