Drug product
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
D-0758-2023
Product summary
- Event
- Event 92058
- Status
- Terminated
- Classification
- Class II
- Quantity
- 105,361 bottles
- Official record key
drug-enforcement:D-0758-2023
Official wording
Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Code information: 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
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations