Status
Completed
Drug Enforcement D-0633-2024
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.
Classification
Class III
Report Date
August 21, 2024
Termination Date
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Product Information
- Product description
- 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
- Product quantity
- 96 vials
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed to one distributor
Location & Firm
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Address
-
3 Skyline Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0633-2024
- Event ID
- 95125
- Recall initiation date
- August 7, 2024
- Center classification date
- August 13, 2024
- Code info
- Lot # AD12890, Exp 09/30/2024
- More code info
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