The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0419-2023·Announced 2023-03-08

Pirfenidone tablets recalled due to manufacturing process deviations

Accord Healthcare recalls Pirfenidone tablets due to manufacturing practice deviations found during FDA inspection. The recall affects 2,614 cartons distributed in the US, 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: FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing process deviation discovered during inspection, making this a precautionary recall rather than one involving a specific identified safety hazard.

Plain-English summary

Accord Healthcare, Inc. is recalling Pirfenidone tablets (267 mg, 90-count bottles) distributed in the United States, Puerto Rico, and Canada. A total of 2,614 cartons manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India are affected.

The recall was issued following an FDA inspection that identified current good manufacturing practice (CGMP) deviations in the manufacturing process. These deviations indicate that manufacturing procedures did not meet FDA standards required to ensure drug quality and safety.

Affected product batches are: - Batches P2202518 and P2202512 with expiration date 4/30/2024 - Batches P2204588 and P2204589 with expiration date 7/31/2024

Patients taking Pirfenidone should contact their healthcare provider with questions about their medication. Healthcare providers and pharmacies should check inventory against the recalled batch codes and take appropriate action regarding affected product.

The recalled product

Product
PIRFENIDONE (PIRFENIDONE)
Brand
PIRFENIDONE
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Prescription Tablet
Hazard
Affected units
2,614

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 (6)

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

UPCs (2)

  • 316729467155
  • 316729467858

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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