Rosuvastatin 5mg tablets — Class II drug recall D-0495-2023
Terminated recall by RemedyRepack Inc., reported 2023-04-12, distributed nationwide. cGMP Deviations
| Recall number | D-0495-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RemedyRepack Inc., Indiana, PA, United States |
| Recall initiated | 2023-03-20 |
| Classified | 2023-03-31 |
| Reported by FDA | 2023-04-12 |
| Terminated | 2023-10-19 |
| Distributed | Nationwide (US) |
| Quantity | 399 bottles |
| Reason classes | cgmp |
| NDC | 70518-3519-00 |
| Lot numbers | J0646383-091422, J0654053-101822, J0661225-111522, J0668398-121422 |
| Expiration dates | 2023-09-30, 2023-11-30, 2023-12-31 |
Product
Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00.
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-0495-2023. 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.