PlainRecalls
FDA Drug Moderate Class II Terminated

Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Reported: April 5, 2023 Initiated: March 13, 2023 #D-0483-2023

Product Description

Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Reason for Recall

cGMP deviations

Details

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

Frequently Asked Questions

What product was recalled?
Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534. Recalled by Direct Rx. Units affected: 51 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-0483-2023.