Accord Healthcare recalls Simvastatin 20mg tablets from specific batches due to FDA inspection deviations. Consumers should check product details and contact the manufacturer for guidance.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling Simvastatin 20mg tablets that were manufactured following FDA inspection deviations. This recall affects specific batches and packaging with unique identifiers. Consumers should check their product details to determine if they are affected.
The recall is due to FDA inspection findings indicating deviations in current Good Manufacturing Practices (CGMP) for the drug products. This means the tablets may not meet safety and quality standards, though the exact nature of the deviations is not specified in the recall notice.
People who have the specific Simvastatin 20mg tablets with the listed NDC and UPC numbers are affected. Those taking this medication for cholesterol management are most at risk.
Check for the 90-count bottle with NDC 16729-005-15 or UPC 3 16729 00515 9, or the 1,000-count bottle with NDC 16729-005-17 or UPC 3 16729 00517 3. The product was manufactured by Intas Pharmaceuticals in India and distributed by Accord Healthcare in the US.
Identify your Simvastatin tablets by checking the NDC number (16729-005-15 or 16729-005-17) and UPC code.
The FDA found deviations in current Good Manufacturing Practices (CGMP) during an inspection, which means the product may not meet safety and quality standards.
Check your product details to see if you have the recalled batches. Contact Accord Healthcare directly for further instructions.
The recall indicates potential quality issues, but the specific risks are not detailed in the official notice.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0410-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0410-2023 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.
