Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., ...
FDA Recall #D-0420-2023 — Class II — February 7, 2023
Product Description
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 for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Recalling Firm
Accord Healthcare, Inc. — Durham, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2641 bottles
Distribution
United States including Puerto Rico and Canada
Code Information
Batches: P2202519, P2202513 Exp. Date 4/30/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated