Accord Healthcare is recalling Simvastatin 40mg tablets (NDC 16729-006-15 and 16729-006-17) after FDA inspection found manufacturing deviations. Consumers should check their product details and contact the manufacturer for guidance.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling Simvastatin 40mg tablets that were manufactured following an FDA inspection with quality control deviations. This recall affects specific batches and packaging, and consumers should check their product details to determine if they have recalled items.
The recall is due to FDA inspections finding manufacturing deviations in the production of these tablets. This means the tablets may not meet the required quality standards, potentially affecting their safety and effectiveness. However, the specific risks are not detailed in the recall notice.
People who have the recalled Simvastatin 40mg tablets (NDC 16729-006-15 or 16729-006-17) from the listed batches and expiration dates. Those taking this medication for cholesterol management are most at risk if they use the recalled products.
Check for the product name 'Simvastatin Tablets USP 40 mg Rx Only', packaging with NDC 16729-006-15 (90-count) or NDC 16729-006-17 (1,000-count), and the listed batch numbers and expiration dates.
Look for the NDC codes 16729-006-15 or 16729-006-17 on the packaging to determine if your tablets are part of the recall.
The FDA found manufacturing deviations during an inspection, which means the tablets may not meet quality standards. The specific risks are not detailed in the recall notice.
Check the NDC codes on the packaging: 16729-006-15 (90-count) or 16729-006-17 (1,000-count), along with the listed batch numbers and expiration dates.
The recall notice does not specify a remedy, so contact Accord Healthcare directly for guidance on next steps.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0411-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0411-2023 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.
