Class II
Terminated
Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories
This recall has been terminated (originally issued May 31, 2023).
- Company
- Amerisource Health Services Llc
- Recall Initiated
- March 17, 2023
- Posted
- May 31, 2023
- Recall Number
- D-0758-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 105,361 bottles
- Firm Location
- Columbus, OH, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Distribution
Nationwide USA
Lot / Code Info
Batches a)P2003493, EXP 05/31/2023; P2100120, EXP 11/30/2023; P2100683, EXP 01/31/2024; P2106002, EXP 07/31/2024; R2200148, EXP 12/31/2024; R2201125, EXP 06/30/2025 b) P2003403, EXP 05/31/2023; b) P2005800, EXP 09/30/2023; P2101156, EXP 01/31/2024; P2105401, EXP 07/31/2024; R2200083, EXP 12/31/2024; R2201004, EXP 07/31/2025
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