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Accord Healthcare, Inc. recalls Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 277

Recalled March 8, 2023 · FDA recall D-0419-2023 · Accord Healthcare

Hazard
CGMP Deviations: recalling drug products following an FDA inspection. · FDA Class II
Units
2614 cartons
Sold at
United States including Puerto Rico and Canada

Description

CGMP Deviations: recalling drug products following an FDA inspection.

Product
Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Bottle NDC 16729-467-15, UPC 3 16729 46715 5; Carton NDC 16729-467-85, UPC 3 16729 46785 8.
Manufacturer(s)
Accord Healthcare, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov