AMIVAS (US), LLC recalls Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01)
Recalled October 13, 2021 · FDA recall D-0002-2022 · AMIVAS (US)
Hazard
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance. · FDA Class II
Units
292 cartons
Sold at
Product was distributed to 3 major distributors who may have further distributed the product to various medical centers, hospitals and hospital pharmacies nationwide in the USA.
Description
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
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.
Manufacturer(s)
AMIVAS (US), LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →