Class III
Completed
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
- Recall Initiated
- August 7, 2024
- Posted
- August 21, 2024
- Recall Number
- D-0633-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 96 vials
- Firm Location
- Hawthorne, NY, United States
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.
Distribution
Product was distributed to one distributor
Lot / Code Info
Lot # AD12890, Exp 09/30/2024
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