Drug recall D-0633-2024
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 for recall
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.
Lots and codes
Lot # AD12890, Exp 09/30/2024
Recall details
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY
- Quantity
- 96 vials
- Distribution
- Product was distributed to one distributor
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 7, 2024
Related products
- NDC 51672-3007 Hydrocortisone and Acetic Acid · Hydrocortisone 10.4 mg/mL; Acetic Acid 20.8 mg/mL · Sun Pharmaceutical Industries, Inc.