Status
Terminated
Drug Enforcement D-0459-2023
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, 0.5mg, 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.
- 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-0459-2023
- Event ID
- 91786
- Recall initiation date
- March 2, 2023
- Center classification date
- March 10, 2023
- 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
- More code info
- —