Artesunate for Injection recalled over sterility concerns

Recall date

September 27, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

AMIVAS (US), LLC recalls Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01)…

Recall number

D-0002-2022

FDA classification

Class II

Brand / firm

AMIVAS (US), LLC

Sold / distributed

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.

Why it was recalled

Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.