Reported Apr 5, 2023 · Terminated

Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct…

Direct Rx

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Direct Rx · 94 Worldwide Dr · Dawsonville, GA · 30534-6828

Is this the product you have?

  • Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90
  • Packaged and Distributed ByDirect Rx, Dawsonville, GA 30534
Lot codes and dates
  • Lot
  • expiry
    • 28AP2212
    • exp 7/31/2024
    • 24MA2230
    • exp 7/31/2024
    • 11JA2203
    • exp 3/31/2023
    • 02FE2217
    • exp 2/28/2023
    • 10DE2126
    • exp 2/28/2023
    • 25MA2201
    • exp 5/31/2023
    • 28FE2230
    • exp 5/31/2023
Amount recalled
269 bottles

This recall covers 11 products

The agency filed one notice per product. You are reading one of them; the other 10 are below.

Where it was sold

  • Nationwide

Why it was recalled

cGMP deviations

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 17, 2024 · Data as of Sep 19, 7:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.