The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0420-2023·Announced 2023-03-08

Pirfenidone Tablets Recalled Due to Manufacturing Compliance Deviations

Accord Healthcare is recalling Pirfenidone 801 mg tablets due to Current Good Manufacturing Practice deviations identified during an FDA inspection. Affected batches P2202519 and P2202513 were distributed in the United States, Puerto Rico, and Canada.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall initiated due to manufacturing facility compliance deviations identified during inspection. No illnesses or injuries have been reported. The recall is precautionary in nature without specific product hazard details.

Plain-English summary

Accord Healthcare, Inc. is recalling Pirfenidone Tablets 801 mg following FDA identification of Current Good Manufacturing Practice (CGMP) deviations during a facility inspection. The recalled batches are P2202519 and P2202513, with an expiration date of 4/30/2024, affecting approximately 2,641 bottles.

The affected product was distributed in the United States, Puerto Rico, and Canada. The manufacturer is Intas Pharmaceuticals Limited in Ahmedabad, India, and the product is distributed by Accord Healthcare, Inc., based in Durham, North Carolina.

Patients currently taking this medication should contact their healthcare provider or pharmacist before taking any action regarding their treatment. Healthcare providers and dispensaries should address inquiries to Accord Healthcare, Inc. or the FDA's drug recall database for additional information.

The recalled product

Product
PIRFENIDONE (PIRFENIDONE)
Brand
PIRFENIDONE
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Prescription Pharmaceutical
Hazard
Affected units
2,641

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Batches: P2202519
  • P2202513 Exp. Date 4/30/2024

UPCs (1)

  • 316729468152

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 67 recalled by Accord Healthcare, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 67 products in this recall →

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