RemedyRepack Inc. recalls Simvastatin 10mg tablets with specific NDC codes due to cGMP deviations. These prescription-only medications may have quality issues affecting safety.
cGMP Deviations
RemedyRepack Inc. is recalling Simvastatin 10 mg tablets in 30-count and 90-count bottles with specific NDC numbers because of manufacturing quality control issues. This recall affects people who have these prescription medications and could pose risks if the tablets are used without addressing the quality concerns.
The recall is due to cGMP (current Good Manufacturing Practice) deviations, which means the tablets were produced under quality control standards that did not meet regulatory requirements. This could potentially affect the safety and effectiveness of the medication.
Prescription holders of Simvastatin 10 mg tablets with the listed NDC codes are affected. Those with the specific bottle lot numbers and expiration dates mentioned in the recall are at risk.
Check for 30-count or 90-count bottles of Simvastatin 10 mg tablets with NDC numbers 70518-0064-01 or 70518-0064-00. Look for specific lot numbers and expiration dates listed in the recall notice.
Identify your Simvastatin 10 mg tablets by checking the NDC code on the bottle and the lot number and expiration date.
The recall is due to cGMP deviations, which means the manufacturing process did not meet quality control standards.
The official notice does not specify a remedy, so you should contact your healthcare provider for advice on whether to stop using the medication.
Yes, the recall lists specific lot numbers and expiration dates for the affected tablets.
We’ve drafted a message you can send RemedyRepack to request your refund or repair — edit it as you like.
Subject: Recall D-0496-2023 — RemedyRepack RemedyRepack Hello, I own a RemedyRepack that is covered by recall D-0496-2023 from RemedyRepack. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
