Drug product
Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
D-0757-2023
Product summary
- Event
- Event 92058
- Status
- Terminated
- Classification
- Class II
- Quantity
- 63,335 bottles
- Official record key
drug-enforcement:D-0757-2023
Official wording
Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Code information: Batches a) P2002616, EXP 04/30/2023; P2006509, EXP 11/30/2023; P2103572, EXP 04/30/2024; P2106811, EXP 09/30/2024; R2200578, EXP 04/30/2025 b)P2100095, EXP 11/30/2023; P2100624, EXP 01/31/2024; P2101780, EXP 02/29/2024; P2107383, EXP 09/30/2024; P2201505, EXP 02/28/2025; R2201109, EXP 06/30/2025
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations