Direct Rx recalls 30-count and 90-count Simvastatin 10mg tablets due to cGMP deviations. Affected lots expire by 10/31/23 and 6/30/23. Consumers should check their bottle labels for NDC numbers.
cGMP deviations
Direct Rx is recalling 30-count and 90-count Simvastatin 10mg tablets that were made with cGMP deviations. This means the medication may not be safe or effective, so affected consumers should stop using these specific lots.
cGMP deviations refer to failures in the manufacturing process that could affect the quality, safety, or effectiveness of the medication. This means the tablets might not work as intended or could be harmful to users.
People who have the 30-count or 90-count Simvastatin 10mg tablets with specific NDC numbers and expiration dates listed in the recall notice are affected. Those taking this medication for cholesterol management are most at risk.
Check your Simvastatin 10mg tablets for the NDC numbers 61919-0688-30 (30-count) or 61919-0688-90 (90-count). The expiration dates for these lots are listed as 10/31/23, 6/30/23, 3/31/23, 5/32/23, and 3/31/23.
Look for the NDC numbers 61919-0688-30 or 61919-0688-90 on the bottle label.
The recall states there were cGMP deviations, which means the tablets may not be safe or effective. Affected lots should not be used.
Check for the NDC numbers 61919-0688-30 (30-count) or 61919-0688-90 (90-count) on the bottle label. The expiration dates for these lots are listed as 10/31/23, 6/30/23, 3/31/23, 5/32/31, and 3/31/23.
The recall does not specify a remedy, so affected consumers should stop using the tablets and contact their healthcare provider for advice.
We’ve drafted a message you can send Direct Rx to request your refund or repair — edit it as you like.
Subject: Recall D-0484-2023 — Direct Rx Direct Rx Hello, I own a Direct Rx that is covered by recall D-0484-2023 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.
