Accord Healthcare recalls Pirfenidone Tablets 267mg 90-count bottles due to FDA inspection finding manufacturing quality deviations. This is a prescription-only medication.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling Pirfenidone Tablets 267mg 90-count bottles because an FDA inspection found quality issues in the manufacturing process. This is a prescription-only medication that could pose risks if the product was not made correctly.
The FDA identified manufacturing quality deviations during an inspection. This means the medication may not be produced to the correct standards, potentially affecting its safety and effectiveness.
Prescription patients who received Pirfenidone Tablets 267mg 90-count bottles manufactured by Intas Pharmaceuticals in India between specific batches and expiration dates. Patients with the prescription medication are most at risk.
Check for the bottle NDC 16729-467-15, carton NDC 16729-467-85, and specific batch numbers (P2202518, P2202512, P2204588, P2204589) with expiration dates of April 30, 2024 or July 31, 2024.
Verify the bottle NDC code 16729-467-15, carton NDC code 16729-467-85, and batch numbers listed in the recall notice.
The FDA identified manufacturing quality deviations during an inspection, which means the medication may not be produced to the correct standards.
Check the product details against the recall information to see if you have the affected items. If you do, contact your healthcare provider for guidance.
The recall notice does not specify a deadline for action, but you should check the product details to confirm if it is affected.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0419-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0419-2023 from Accord Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
