Status
Terminated
Drug Enforcement D-0463-2023
CGMP Deviations: Potential risk of Cross Contamination
Classification
Class II
Report Date
March 22, 2023
Termination Date
March 21, 2024
Product Information
- Product description
- 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
- Product quantity
- N/A
- Reason for recall
- CGMP Deviations: Potential risk of Cross Contamination
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- USA nationwide.
Location & Firm
- Recalling firm
- Breckenridge Pharmaceutical, Inc
- Address
-
15 Massirio Dr Ste 201, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0463-2023
- Event ID
- 91786
- Recall initiation date
- March 2, 2023
- Center classification date
- March 10, 2023
- Code info
- Lot # 5210147, Exp 12/2023
- More code info
- —