Rosuvastatin 10mg tablets — Class II drug recall D-0501-2023
Terminated recall by RemedyRepack Inc., reported 2023-04-12, distributed nationwide. cGMP Deviations
| Recall number | D-0501-2023 |
|---|---|
| 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) |
| Reason classes | cgmp |
| NDC | 70518-0375-00, 70518-0375-01, 70518-0375-03 |
| Lot numbers | B1862598-092022, B1970205-112022, B2011634-121322, B2070444-012023, B2075815-012523, B2077226-012523 |
| Expiration dates | 2023-10-31, 2023-12-31, 2024-01-31, 2024-03-31, 2024-06-30, 2025-07-31, 2025-09-30 |
Product
Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
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-0501-2023. 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.