FDAHealthAugust 7, 2024
Taro Pharmaceuticals U.S.A., Inc. — 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
⚠️ 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.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- August 7, 2024
Product was distributed to one distributor
What's affected?
- 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
- Lot code
- AD12890
Additional details
Lot # AD12890, Exp 09/30/2024
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 96 vials.
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