Status
Terminated
Drug Enforcement D-0458-2023
CGMP Deviations: Potential risk of Cross Contamination
Classification
Class II
Report Date
March 22, 2023
Termination Date
March 21, 2024
Product Information
- Product description
- Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0704-01), b) 500-count bottle and c) 1,000-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.
- Product quantity
- N/A
- Reason for recall
- CGMP Deviations: Potential risk of Cross Contamination
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- USA nationwide.
Location & Firm
- Recalling firm
- Breckenridge Pharmaceutical, Inc
- Address
-
15 Massirio Dr Ste 201, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0458-2023
- Event ID
- 91786
- Recall initiation date
- March 2, 2023
- Center classification date
- March 10, 2023
- Code info
- Lot #a) 5210734, Exp 4/30/2023; 5211451, Exp 8/31/2024; 5220529, Exp 4/30/2025; b) 5210735, Exp 4/30/2023; 5210736, Exp 4/30/2023, 5210993, Exp 5/31/20; 5210994, Exp 5/31/2023, 5211100, Exp 6/30/2023, 5211452, Exp 8/31/2024, 5211453, Exp 8/31/2024, 5211454, Exp 8/31/2024, 5211640, Exp 10/31/2024, 5211641, Exp 10/31/2024; c) 5210737, Exp 4/30/2023; 5210995, Exp 5/31/2023; 5211101, Exp 6/30/2023, 5211269, Exp 7/31/2024, 5211270, Exp 7/31/2024, 5211271, Exp 7/31/2024.
- More code info
- —