Accord Healthcare recalls 10mg Simvastatin tablets (NDC 16729-004-15 and 16729-004-17) after FDA inspection found manufacturing deviations. Consumers should check product labels for batch numbers and expiration dates.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling 10mg Simvastatin tablets due to manufacturing deviations found during an FDA inspection. This recall affects specific bottle sizes and batch numbers with potential risks to patient safety.
The recall is triggered by FDA inspections finding manufacturing deviations in the production process. This means the tablets may not meet quality standards, potentially affecting safety and effectiveness for patients.
People who have the recalled Simvastatin tablets (90-count or 1,000-count bottles) from Accord Healthcare. Those with prescriptions for this medication are most at risk.
Check the product label for the NDC code 16729-004-15 (90-count bottle) or 16729-004-17 (1,000-count bottle). Also look for batch numbers and expiration dates listed in the recall notice.
Look for the NDC code 16729-004-15 or 16729-004-17 on the bottle to identify the recalled product.
The FDA found manufacturing deviations during an inspection, which means the tablets may not meet quality standards.
The recall record does not specify a remedy, so contact your healthcare provider for guidance.
Check the product label for NDC codes 16729-004-15 (90-count bottle) or 16729-004-17 (1,000-count bottle).
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0409-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0409-2023 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.
