D-0462-2023 Class II Terminated
FDA drug recall D-0462-2023 was initiated by Breckenridge Pharmaceutical, Inc on March 2, 2023 and is designated Class II. Reason for recall: CGMP Deviations: Potential risk of Cross Contamination The recall status is terminated (terminated March 21, 2024). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- March 22, 2023
- Initiation Date
- March 2, 2023
- Termination Date
- March 21, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-900-01
Reason for Recall
CGMP Deviations: Potential risk of Cross Contamination
Distribution Pattern
USA nationwide.
Code Information
Lot # 5210085, Exp 12/2023; 5210248, Exp 01/2024; 5220796, Exp 07/2025