FDAClass IIMarch 8, 2023

Pirfenidone Tablets 267 mg 90-count bottle x3/Carton recall: CGMP Deviations

Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas…

Why was Pirfenidone Tablets 267 mg 90-count bottle x3/Carton recalled?

CGMP Deviations: recalling drug products following an FDA inspection.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batches: P2202518, P2202512, Exp. Date 4/30/2024, P2204588, P2204589, Exp. Date 7/31/2024

Product
Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas…
Recalling firm
Accord Healthcare, Inc.
Quantity
2614 cartons
Distribution
United States including Puerto Rico and Canada
Recall date
March 8, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls