FDAFDA · Food and drugs·Recall number D-0002-2022
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.
Published October 13, 2021 · Recall initiated: September 27, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AMIVAS (US), LLC
- Distributor
- 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
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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