Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories

Recall Number: D-0759-2023

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, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories