FDAClass IIMarch 22, 2023

Alprazolam Tablets recall: CGMP Deviations

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.

Why was Alprazolam Tablets recalled?

CGMP Deviations: Potential risk of Cross Contamination

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

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.
Recalling firm
Breckenridge Pharmaceutical, Inc
Quantity
N/A
Distribution
USA nationwide.
Recall date
March 22, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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