Direct Rx recalls Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61
Recalled April 5, 2023 · FDA recall D-0485-2023 · Direct Rx
Hazard
cGMP deviations · FDA Class II
Units
30 count: 5 bottles; 90 count: 53 bottles
Sold at
Nationwide in the USA
Description
cGMP deviations
Product
Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Manufacturer(s)
Direct Rx
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →