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

FDA recall notice · announced October 13, 2021 · Amivas (us)

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

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.
Lot/code information: Manufacturer Lot Numbers: AR479E01, exp. date 11/03/2022; AR479E02, exp. date 11/09/2022; AR479E03, exp. date 11/16/2022; Cardinal Health Packaging Solutions Lot Numbers: 7507001 and 7508001
Quantity: 292 cartons
Status: Terminated
Products in this recall event:
- 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); 4x (D-0002-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.