Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials art...
FDA Recall #D-0002-2022 — Class II — September 27, 2021
Product Description
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.
Recalling Firm
AMIVAS (US), LLC — Frederick, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
292 cartons
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.
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated