Direct Rx recalls 5mg Simvastatin tablets due to cGMP deviations. Affected lots expire 6/30/23. Consumers should check product details and contact manufacturer.
cGMP deviations
Direct Rx is recalling 5mg Simvastatin tablets that were made with cGMP deviations. This means the tablets may not meet quality standards and could be unsafe for use.
cGMP deviations refer to failures in the manufacturing process that could affect the safety and quality of the medication. This might mean the tablets do not meet the required standards for effectiveness or safety.
People who have the 5mg Simvastatin tablets with the listed lot numbers and expiration dates (expiring 6/30/23) are affected. Those taking this medication for cholesterol management are most at risk.
Check for the 90-count bottle labeled 'Simvastatin, USP, 5 mg Tablets, Rx Only' with lot numbers 03JA2209, 28FE2225, 28AP2211, or 07AP2203 that expire by 6/30/23.
Look for the lot numbers and expiration date on the bottle to confirm if it's affected.
The recall is due to cGMP deviations, which are manufacturing process failures that could affect the safety and quality of the medication.
The official recall notice does not specify a remedy or action for affected products.
Check the lot numbers on the bottle: 03JA2209, 28FE2225, 28AP2211, or 07AP2203 with an expiration date of 6/30/23.
We’ve drafted a message you can send Direct Rx to request your refund or repair — edit it as you like.
Subject: Recall D-0483-2023 — Direct Rx Direct Rx Hello, I own a Direct Rx that is covered by recall D-0483-2023 from Direct Rx. 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.
