Accord Healthcare is recalling Simvastatin 80mg tablets from specific batches after FDA inspection found manufacturing deviations. Consumers should check product labels for NDC codes and batch numbers to determine if their tablets are affected.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling Simvastatin 80mg tablets due to manufacturing deviations found during an FDA inspection. This recall affects specific batches of tablets sold in the U.S. and requires consumers to check their product labels for the NDC and batch numbers to confirm if they have affected items.
The FDA identified manufacturing deviations in the production process for these tablets. This means the tablets may not meet quality standards and could potentially be unsafe for use, though the exact risk is not specified in the recall notice.
People who have the specific 90-count or 1,000-count bottles of Simvastatin 80mg tablets with the listed NDC and batch numbers are affected. Those taking this medication for cholesterol management are most at risk if they have the recalled batches.
Check the product label for the NDC code 16729-007-15 (90-count bottle) or 16729-007-17 (1,000-count bottle). Also look for the batch numbers listed in the recall notice, such as R2100387, P2102556, and others.
Look for the NDC code on the bottle label: 16729-007-15 for 90-count bottles or 16729-007-17 for 1,000-count bottles.
Check the batch numbers listed in the recall notice, such as R2100387, P2102556, or others, to confirm if your tablets are affected.
The FDA found manufacturing deviations during an inspection, which means the tablets may not meet quality standards. The exact risk is not specified in the recall notice.
Check the product label for the NDC code 16729-007-15 (90-count bottle) or 16729-007-17 (1,000-count bottle) and the batch numbers listed in the recall notice.
The recall notice does not specify a remedy, so contact Accord Healthcare directly for further instructions.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0412-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0412-2023 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.
