Status
Terminated
Drug Enforcement D-0089-2024
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 stability testing.
Classification
Class III
Report Date
November 15, 2023
Termination Date
August 27, 2024
Product Information
- Product description
- 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. Hawthorne, NY 10532. NDC 51672-3007-1
- Product quantity
- 11,196 bottles
- 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 stability testing.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Taro Pharmaceuticals Inc.
- Address
-
130 East Dr
Canada - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0089-2024
- Event ID
- 93337
- Recall initiation date
- November 6, 2023
- Center classification date
- November 6, 2023
- Code info
- Lot# AC86809, AC86812, Exp Date: 01/31/2024
- More code info
- —