FDA recall D-0002-2022

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.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2021-09-27

Report date

2021-10-13

Termination date

2023-06-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Frederick, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0002-2022