D-0483-2023 Class II Terminated
FDA drug recall D-0483-2023 was initiated by Direct Rx on March 13, 2023 and is designated Class II. Reason for recall: cGMP deviations The recall status is terminated (terminated June 17, 2024). Affected quantity: 51 bottles.
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
- 51 bottles
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
Distribution Pattern
Nationwide in the USA
Code Information
Lot, expiry: 03JA2209, 28FE2225, 28AP2211, 07AP2203, exp 6/30/23