D-0461-2023 Class II Terminated
FDA drug recall D-0461-2023 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, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC 51991-0707-05), 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 # 5210546, exp. date 3/31/2023, 100's Bottle 5210547, exp. date 3/31/2023, 500's Bottle 5210548, exp. date 3/31/2023, 500's Bottle 5210642, exp. date 3/31/2023, 100's Bottle 5210643, exp. date 3/31/2023, 100's Bottle 5210644, exp. date 3/31/2023, 500's Bottle 5210766, exp. date 4/30/2023, 100's Bottle 5210767, exp. date 4/30/2023, 100's Bottle 5210768, exp. date 4/30/2023, 500's Bottle 5210999, exp. date 5/31/2023, 500's Bottle 5211000, exp. date 5/31/2023, 500's Bottle 5211001, exp. date 5/31/2023, 500's Bottle 5211002, exp. date 5/31/2023, 500's Bottle 5211003, exp. date 5/31/2023, 500's Bottle 5211004, exp. date 6/30/2023, 500's Bottle 5211005, exp. date 6/30/2023, 500's Bottle 5211006, exp. date 6/30/2023, 500's Bottle 5211055, exp. date 6/30/2023, 500's Bottle 5211332, exp. date 7/31/2024, 500's Bottle 5211333, exp. date 7/31/2024, 500's Bottle 5211339, exp. date 7/31/2024, 100's Bottle 5211340, exp. date 7/31/2024, 100's Bottle 5211341, exp. date 7/31/2024, 100's Bottle 5211363, exp. date 8/31/2024, 100's Bottle 5220313, exp. date 2/28/2025, 500's Bottle 5220314, exp. date 2/28/2025, 500's Bottle 5220315, exp. date 2/28/2025, 500's Bottle