Recalls / Class II
Class IID-0461-2023
Product
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.
- Affected 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
Why it was recalled
CGMP Deviations: Potential risk of Cross Contamination
Recalling firm
- Firm
- Breckenridge Pharmaceutical, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 15 Massirio Dr Ste 201, N/A, Berlin, Connecticut 06037-2352
Distribution
- Quantity
- N/A
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2023-03-02
- FDA classified
- 2023-03-10
- Posted by FDA
- 2023-03-22
- Terminated
- 2024-03-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0461-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.