Recall: D-0420-2023

Class II - Potentially Harmful

Class IIClassification

2023-02-07Initiated

TerminatedStatus

Accord Healthcare, Inc.Firm

Product

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.

Reason

CGMP Deviations: recalling drug products following an FDA inspection.

Distribution

United States including Puerto Rico and Canada

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.