Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-003-01 UPC 3 16729 00301 8; b) 500-count NDC 16729-003-16 UPC 3 16729 00316 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

Recall Number: D-0395-2023

Firm: Accord Healthcare, Inc.

Classification: Class II

Status: Terminated

Report Date: 20230308

Initiation Date: 20230207

Termination Date: 20240422

CGMP Deviations: recalling drug products following an FDA inspection.

Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-003-01 UPC 3 16729 00301 8; b) 500-count NDC 16729-003-16 UPC 3 16729 00316 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA