Accord Healthcare recalls 5mg Finasteride tablets due to FDA inspection finding CGMP deviations. Products with specific NDC codes and batch numbers are affected. Consumers should check their bottles for the listed identifiers.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling 5mg Finasteride tablets that were manufactured following FDA inspection findings of CGMP deviations. This recall affects specific bottle sizes and batch numbers with expiration dates up to May 2025. The product is prescription-only and must be handled carefully by authorized medical professionals.
The recall is triggered by FDA inspection findings that the manufacturing process did not meet current Good Manufacturing Practices (CGMP) standards. This means the product may not be safe or effective as intended, though the specific risks are not detailed in the recall notice.
Prescription holders of Finasteride 5mg tablets with the listed NDC codes and batch numbers are affected. Patients who have been prescribed this medication should check their bottles against the provided identifiers.
Check for bottles labeled with NDC codes 16729-090-10, 16729-090-15, 16729-090-01, or 16729-090-16. Also look for batch numbers listed in the expiration date ranges provided in the recall notice.
Look for the NDC codes and batch numbers listed in the recall notice to confirm if your product is affected.
The FDA found that the manufacturing process did not meet current Good Manufacturing Practices (CGMP) standards during an inspection.
Check your product labels against the NDC codes and batch numbers listed in the recall notice to determine if it is affected.
The recall notice does not specify any risk of serious injury or harm from the product.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0392-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0392-2023 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.
