Accord Healthcare recalls 5mg Simvastatin tablets due to FDA inspection finding manufacturing deviations. Affected products include specific NDC and UPC codes with batch dates through 2025. Consumers should check their bottles for the listed identifiers.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling Simvastatin 5mg tablets after an FDA inspection found manufacturing deviations. This recall affects specific bottle sizes and batch numbers with expiration dates up to April 2025. If you have these products, you should check the labels and contact the manufacturer for guidance.
The FDA identified manufacturing deviations during an inspection, which means the drug may not meet quality standards. However, the recall does not specify what harm could result from using these products. The hazard is described as a CGMP (current good manufacturing practice) deviation, which typically relates to production quality but not immediate safety risks.
People who have the recalled Simvastatin 5mg tablets with the specific NDC and UPC codes listed in the recall notice. Those taking this medication for cholesterol management are most at risk if they use the affected products.
Check the bottle for the NDC code 16729-156-15 (90-count) or 16729-156-17 (1,000-count) and the UPC code 3 16729 15615 8 or 3 16729 15617 2. Also look for batch numbers like R2100818 through R2200768 with expiration dates up to April 2025.
Look for the NDC code 16729-156-15 or 16729-156-17, UPC code 3 16729 15615 8 or 3 16729 15617 2, and batch numbers listed in the recall notice.
The FDA found manufacturing deviations during an inspection, which means the product may not meet quality standards. The exact nature of the deviation is not specified in the recall notice.
The recall does not specify that the tablets are unsafe for use; it only indicates a manufacturing deviation. You should check the labels to see if your product is affected.
Check the product labels for the NDC and UPC codes listed in the recall. If you have the affected products, contact Accord Healthcare 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-0408-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0408-2023 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.
