Skip to content
Recall Observatory FDA recall evidence

Drug product

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.

D-0458-2023

March 02, 2023

Class II

Product summary

Firm
Breckenridge Pharmaceutical, Inc
Event
Event 91786
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0458-2023

Official wording

Reason: CGMP Deviations: Potential risk of Cross Contamination

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.

Distribution pattern: USA nationwide.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations