FDA-Drug2023-04-05Class II

Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx
Hazard

cGMP deviations

Sold states
Nationwide in the USA
Affected count
30 count: 6 bottles; 90 count: 106 bottles
Manufactured in
94 Worldwide Dr, N/A, Dawsonville, GA, United States
Products
Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0484-2023

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief