Artesunate for Injection — Class II drug recall D-0002-2022
Terminated recall by AMIVAS (US), LLC, reported 2021-10-13, distributed nationwide. Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance
| Recall number | D-0002-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AMIVAS (US), LLC, Frederick, MD, United States |
| Recall initiated | 2021-09-27 |
| Classified | 2021-10-05 |
| Reported by FDA | 2021-10-13 |
| Terminated | 2023-06-27 |
| Distributed | Nationwide (US) |
| Quantity | 292 cartons |
| Reason classes | sterility |
| NDC | 73607-0001-01, 73607-0001-02, 73607-0001-10, 73607-0001-11 |
| Lot numbers | 7507001, 7508001, AR479E01, AR479E02, AR479E03 |
| Expiration dates | 2022-11-03, 2022-11-09, 2022-11-16 |
Product
Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01) and 2 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-11); 4x4 pack containing 4 Single-dose vials artesunate (73607-001-01) and 4 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-10), Rx only, Mfg for: Amivas, LLC, 1209 Orange St., Wilmington, Delaware 19801.
Reason for recall
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
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-0002-2022. 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.