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
Recall Number: D-0757-2023
Firm: Amerisource Health Services LLC
Classification: Class II
Status: Terminated
Report Date: 20230531
Initiation Date: 20230317
Termination Date: 20240906
Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Product Description
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