Recalls / Class II
Class IID-0463-2023
Product
Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-901-01
- Affected lot / code info
- Lot # 5210147, Exp 12/2023
Why it was recalled
CGMP Deviations: Potential risk of Cross Contamination
Recalling firm
- Firm
- Breckenridge Pharmaceutical, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 15 Massirio Dr Ste 201, N/A, Berlin, Connecticut 06037-2352
Distribution
- Quantity
- N/A
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2023-03-02
- FDA classified
- 2023-03-10
- Posted by FDA
- 2023-03-22
- Terminated
- 2024-03-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0463-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.