Accord Healthcare recalls 801 mg Pirfenidone Tablets (Rx only) manufactured in India following FDA inspection. Products may have CGMP deviations. Consumers should check NDC 16729-468-15 and batch numbers for affected items.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling 801 mg Pirfenidone Tablets (Rx only) because an FDA inspection found manufacturing quality issues. This recall affects patients who need this prescription medication for specific conditions.
The FDA identified manufacturing quality deviations during an inspection. This means the medication may not meet safety and quality standards, potentially affecting its effectiveness or safety for patients.
Prescription patients using Pirfenidone Tablets 801 mg for medical conditions. Those with the specific batch numbers or NDC code are most at risk.
Check for the NDC code 16729-468-15 and batch numbers P2202519 or P2202513 on the product label. Products were sold between the manufacturing dates and expire April 30, 2024.
Look for NDC 16729-468-15 and batch numbers P2202519 or P2202513 on the label.
The FDA found manufacturing quality deviations during an inspection, which may affect the medication's safety and effectiveness.
Check for NDC 16729-468-15 and batch numbers P2202519 or P2202513 on the label.
The recall record does not specify a remedy, so contact your healthcare provider for guidance.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0420-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0420-2023 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.
