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.
What this means for you
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.
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