Recalls / Class III
Class IIID-0089-2024
Product
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
- Brand name
- Hydrocortisone And Acetic Acid
- Generic name
- Hydrocortisone And Acetic Acid
- Active ingredients
- Acetic Acid, Hydrocortisone
- Route
- Auricular (otic)
- NDC
- 51672-3007
- FDA application
- ANDA088759
- Affected lot / code info
- Lot# AC86809, AC86812, Exp Date: 01/31/2024
Why it was recalled
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.
Recalling firm
- Firm
- Taro Pharmaceuticals Inc.
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 130 East Dr, Brampton, N/A, Canada
Distribution
- Quantity
- 11,196 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-11-06
- FDA classified
- 2023-11-06
- Posted by FDA
- 2023-11-15
- Terminated
- 2024-08-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0089-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.