D-0486-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 5, 2023
- Initiation Date
- March 13, 2023
- Termination Date
- June 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 269 bottles
Product Description
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
Reason for Recall
cGMP deviations
Distribution Pattern
Nationwide in the USA
Code Information
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.