Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-468-15, UPC 3 16729 46815 2.

Recall Number: D-0420-2023

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.

Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-468-15, UPC 3 16729 46815 2.