Direct Rx Simvastatin 40mg tablets (90-count) with specific lot numbers recalled due to cGMP deviations. Consumers should check their bottles for listed lot numbers and contact the manufacturer for guidance.
cGMP deviations
Direct Rx is recalling 40mg Simvastatin tablets sold in 90-count bottles that had manufacturing quality issues. This recall affects people taking this medication who have the specific lot numbers listed in the notice.
The product was manufactured with deviations from current Good Manufacturing Practices (cGMP). This means the quality of the medication may not meet safety standards, though the exact risk is not specified in the recall notice.
People who have the specific lot numbers listed in the recall notice are affected. Those taking this medication for cholesterol management are most at risk if they use the recalled product.
Check your Direct Rx Simvastatin 40mg 90-count bottles for lot numbers like 28AP2212, 24MA2230, 11JA2203, 02FE2217, 10DE2126, 25MA2201, or 28FE2230. The expiration dates for these lots range from February 2023 to July 2024.
Look for the lot numbers listed in the recall notice on your Direct Rx Simvastatin 40mg 90-count bottle.
The recall notice states there were cGMP deviations, but does not specify if the product is safe to use. Consumers should check the lot numbers and contact Direct Rx for guidance.
The recall notice does not specify a remedy, so you should check the lot numbers and contact Direct Rx for further instructions.
Check the lot numbers on your Direct Rx Simvastatin 40mg 90-count bottle against the list provided in the recall notice.
We’ve drafted a message you can send Direct Rx to request your refund or repair — edit it as you like.
Subject: Recall D-0486-2023 — Direct Rx Direct Rx Hello, I own a Direct Rx that is covered by recall D-0486-2023 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.
