Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC 519
Summary
The FDA issued a Class II for Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0 by Breckenridge Pharmaceutical, Inc. Reason: CGMP Deviations: Potential risk of Cross Contamination.
Details
Source
Drug Recall
External ID
D-0461-2023
Action Date
2023-03-22
Status
Terminated
Category
drug
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.
Lot/Code Info: 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
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-0461-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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