Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991
Summary
The FDA issued a Class II for Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991- by Breckenridge Pharmaceutical, Inc. Reason: CGMP Deviations: Potential risk of Cross Contamination.
Details
Source
Drug Recall
External ID
D-0460-2023
Action Date
2023-03-22
Status
Terminated
Category
drug
Product Description
Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05) and c) 1,000-count bottle (NDC 51991-0706-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.
Lot/Code Info: Lot # 5210645, exp. date 3/31/2023, 500's Bottle 5210646, exp. date 3/31/2023, 500's Bottle 5210647, exp. date 3/31/2023, 500's Bottle 5210648, exp. date 3/31/2023, 1000's Bottle 5210649, exp. date 3/31/2023, 1000's Bottle 5210831, exp. date 4/30/2023, 100's Bottle 5210832, exp. date 4/30/2023, 500's Bottle 5210833, exp. date 4/30/2023, 500's Bottle 5210834, exp. date 4/30/2023, 1000's Bottle 5210835, exp. date 4/30/2023, 1000's Bottle 5210905, exp. date 5/31/2023, 100's Bottle 5210906, exp. date 5/31/2023, 100's Bottle 5210907, exp. date 5/31/2023, 500's Bottle 5210908, exp. date 5/31/2023, 500's Bottle 5210909, exp. date 5/31/2023, 500's Bottle 5210965, exp. date 5/31/2023, 500's Bottle 5210997, exp. date 5/31/2023, 1000's Bottle 5210998, exp. date 5/31/2023, 1000's Bottle 5211175, exp. date 6/30/2023, 1000's Bottle 5211176, exp. date 6/30/2023, 500's Bottle 5211177, exp. date 6/30/2023, 500's Bottle 5211178, exp. date 6/30/2023, 500's Bottle 5211179, exp. date 6/30/2023, 500's Bottle 5211180, exp. date 6/30/2023, 500's Bottle 5211181, exp. date 6/30/2023, 500's Bottle 5211205, exp. date 7/31/2023, 500 s Bottle 5211206, exp. date 7/31/2023, 500's Bottle 5211227, exp. date 7/31/2023, 1000's Bottle 5211228, exp. date 7/31/2023, 100's Bottle 5211229, exp. date 7/31/2023, 1000's Bottle 5211334, exp. date 8/31/2024, 500's Bottle 5211335, exp. date 8/31/2024, 1000's Bottle 5211456, exp. date 8/31/2024 , 500's Bottle 5211457, exp. date 8/31/2024 , 500's Bottle 5211458, exp. date 8/31/2024, 500's Bottle 5211459, exp. date 9/30/2024, 1000's Bottle 5211727, exp. date 11/30/2024, 100's Bottle 5211730, exp. date 11/30/2024, 1000's Bottle 5220028, exp. date 12/31/2024, 1000's Bottle 5220029, exp. date 12/31/2024, 1000's Bottle 5220288, exp. date 2/28/2025, 100's Bottle
Quantity Affected: N/A
Reason for Recall
CGMP Deviations: Potential risk of Cross Contamination
Distribution
USA nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-02
Company
Berlin, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 55 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Breckenridge Pharmaceutical, Inc has 29 FDA actions in our database, including 29 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Breckenridge Pharmaceutical, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Breckenridge Pharmaceutical, Inc have FDA actions?
Breckenridge Pharmaceutical, Inc has 29 FDA actions in our database, including 29 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0460-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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