FDA Drug Moderate Class II Terminated

Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Reported: April 5, 2023 Initiated: March 13, 2023 #D-0486-2023

Product Description

Reason for Recall

cGMP deviations

Details

Recalling Firm: Direct Rx
Units Affected: 269 bottles
Distribution: Nationwide in the USA
Location: Dawsonville, GA

Frequently Asked Questions

What product was recalled? ▼

Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534. Recalled by Direct Rx. Units affected: 269 bottles.

Why was this product recalled? ▼

cGMP deviations

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on April 5, 2023. Severity: Moderate. Recall number: D-0486-2023.

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