Direct Rx recalls 20mg Simvastatin tablets due to cGMP deviations. Affected lots expire through 2025. Consumers should check NDC numbers and lot dates for affected products.
cGMP deviations
Direct Rx is recalling 20mg Simvastatin tablets that were manufactured with cGMP deviations. This means the product may not meet quality standards and could be unsafe for use.
cGMP deviations refer to failures in the manufacturing process that could affect the product's safety and quality. This means the tablets might not be as intended and could pose health risks if used.
People who have the 20mg Simvastatin tablets with NDC 61919-0446-30 (30-count) or NDC 61919-0446-90 (90-count) from Direct Rx. Those with the specific lot numbers listed in the recall are most at risk.
Check the NDC number on the bottle: 61919-0446-30 for 30-count bottles or 61919-0446-90 for 90-count bottles. Look for the lot numbers listed in the recall, which expire through February 2025.
Look for the NDC number on the bottle and compare it to the listed NDCs (61919-0446-30 or 61919-0446-90).
Direct Rx is recalling 20mg Simvastatin tablets due to cGMP deviations in manufacturing.
Check the NDC number on the bottle: 61919-0446-30 for 30-count bottles or 61919-0446-90 for 90-count bottles. Also check the lot numbers listed in the recall.
The recall record does not specify a remedy, so no action is required beyond checking if you have the product.
We’ve drafted a message you can send Direct Rx to request your refund or repair — edit it as you like.
Subject: Recall D-0485-2023 — Direct Rx Direct Rx Hello, I own a Direct Rx that is covered by recall D-0485-2023 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.
