Drug 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
D-0463-2023
Product summary
- Event
- Event 91786
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0463-2023
Official wording
Reason: CGMP Deviations: Potential risk of Cross Contamination
Code information: Lot # 5210147, Exp 12/2023
Distribution pattern: USA nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations