Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 5199
Summary
The FDA issued a Class II for Alprazolam Tablets, USP, 0.5mg, 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-0459-2023
Action Date
2023-03-22
Status
Terminated
Category
drug
Product Description
Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 51991-0705-05) and c) 1,000-count bottle (NDC 51991-0705-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.
Lot/Code Info: Lot # a) 5210673, exp. date 3/31/2023; 5210901, exp. date 5/31/2023; 5211461, exp. date 9/30/2024; 5220291, exp. date 2/28/2025; 5220559, exp. date 5/31/2025; b) 5210650, exp. date 3/31/2023, 5210651, exp. date 3/31/2023 5210652, exp. date 3/31/2023 5210653, exp. date 3/31/2023 5210674, exp. date 3/31/2023 5210732, exp. date 3/31/2023 5210733, exp. date 4/30/2023 5210753, exp. date 4/30/2023 5210902, exp. date 5/31/2023 5210903, exp. date 5/31/2023 5210904, exp. date 5/31/2023 5211231, exp. date 7/31/2023 5211281, exp. date 7/31/2024 5211282, exp. date 7/31/2024 5211283, exp. date 7/31/2024 5211284, exp. date 7/31/2024 5211336, exp. date 7/31/2024 5211337, exp. date 8/31/2024 5211338, exp. date 8/31/2024 5211462, exp. date 9/30/2024 5211463, exp. date 9/30/2024 5211464, exp. date 9/30/2024 5211465, exp. date 9/30/2024 5211516, exp. date 9/30/2024 5211644, exp. date 10/31/2024 5211645, exp. date 10/31/2024 5211690, exp. date 10/31/2024 c) 5210675, exp. date 3/31/2023 5210777, exp. date 4/30/2023 5210778, exp. date 4/30/2023 5210996, exp. date 5/31/2023 5211077, exp. date 6/30/2023 5211078, exp. date 6/30/2023 5211079, exp. date 6/30/2023 5211080, exp. date 6/30/2023 5211364, exp. date 8/31/2024 5211365, exp. date 8/31/2024 5211367, exp. date 8/31/2024 5211366, exp. date 8/31/2024 5211575, exp. date 10/31/2024 5211576, exp. date 10/31/2024 5211694, exp. date 11/30/2024 5220066, exp. date 12/31/2024
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-0459-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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