D-0458-2023 Class II Terminated
FDA drug recall D-0458-2023 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
Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0704-01), b) 500-count bottle and c) 1,000-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.
Reason for Recall
CGMP Deviations: Potential risk of Cross Contamination
Distribution Pattern
USA nationwide.
Code Information
Lot #a) 5210734, Exp 4/30/2023; 5211451, Exp 8/31/2024; 5220529, Exp 4/30/2025; b) 5210735, Exp 4/30/2023; 5210736, Exp 4/30/2023, 5210993, Exp 5/31/20; 5210994, Exp 5/31/2023, 5211100, Exp 6/30/2023, 5211452, Exp 8/31/2024, 5211453, Exp 8/31/2024, 5211454, Exp 8/31/2024, 5211640, Exp 10/31/2024, 5211641, Exp 10/31/2024; c) 5210737, Exp 4/30/2023; 5210995, Exp 5/31/2023; 5211101, Exp 6/30/2023, 5211269, Exp 7/31/2024, 5211270, Exp 7/31/2024, 5211271, Exp 7/31/2024.