Simvastatin — Class II drug recall D-0483-2023
Terminated recall by Direct Rx, reported 2023-04-05, distributed nationwide. cGMP deviations
| Recall number | D-0483-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Direct Rx, Dawsonville, GA, United States |
| Recall initiated | 2023-03-13 |
| Classified | 2023-03-24 |
| Reported by FDA | 2023-04-05 |
| Terminated | 2024-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 51 bottles |
| Reason classes | cgmp |
| NDC | 61919-0710-90 |
| Lot numbers | 03JA2209, 07AP2203, 28AP2211, 28FE2225 |
| Expiration dates | 2023-06-30 |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0483-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.