Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Pirfenidone Tablets 267 mg 90-count bottle x3/Carton Recalled by Accord Healthcare, Inc. Due to CGMP Deviations: recalling drug products following an FDA...

Date: February 7, 2023
Company: Accord Healthcare, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Accord Healthcare, Inc. directly.

Affected Products

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.

Quantity: 2614 cartons

Why Was This Recalled?

CGMP Deviations: recalling drug products following an FDA inspection.

Where Was This Sold?

United States including Puerto Rico and Canada

About Accord Healthcare, Inc.

Accord Healthcare, Inc. has 76 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report