Drug recall
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro…
FDA recall event 93337 · Class III · Taro Pharmaceuticals Inc.
Key facts
| Event ID | 93337 |
|---|---|
| Recall numbers | D-0089-2024 |
| Recalling firm | Taro Pharmaceuticals Inc. |
| Product type | Drugs |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| 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… |
| Initiation date | Nov 6, 2023 |
| Report date | Nov 15, 2023 |
| Termination date | Aug 27, 2024 |
| City | Brampton |
| Country | Canada |
| FEI number | 3002808384 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: