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Class II: temporary or reversible health riskTerminated

Breckenridge Pharmaceutical Alprazolam Tablets Recall

Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01…

Breckenridge Pharmaceutical, Inc · Berlin, CT

Risk level
Class II
Reported by FDA
Mar 22, 2023
Recall ID
D-0460-2023
Check your lot numberHow we source this data

Summary

Breckenridge Pharmaceutical recalled Alprazolam Tablets starting Mar 2, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0460-2023 on Mar 22, 2023. Reason: CGMP Deviations: Potential risk of Cross Contamination. Status: Terminated.

Why it was recalled

CGMP Deviations: Potential risk of Cross Contamination

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 numbers, UPCs & expiration codes

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

Where it was sold

USA nationwide.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0460-2023
Classification
Class II
Status
Terminated
Recall initiated
Mar 2, 2023
FDA report date
Mar 22, 2023
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
Breckenridge Pharmaceutical, Inc

Original FDA data

Every field from FDA enforcement report D-0460-2023, exactly as published.

Show all FDA fields
City
Berlin
State
CT
Status
Terminated
Country
United States
Event ID
91786
Address
15 Massirio Dr Ste 201
Code information
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
Postal code
06037-2352
Report date
Mar 22, 2023
Product type
Drugs
Recall number
D-0460-2023
Classification
Class II
Recalling firm
Breckenridge Pharmaceutical, Inc
Termination date
Mar 21, 2024
Reason for recall
CGMP Deviations: Potential risk of Cross Contamination
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
USA nationwide.
Recall initiation date
Mar 2, 2023
Initial firm notification
Letter
Center classification date
Mar 10, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0460-2023, published Mar 22, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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