Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Artesunate for Injection Recalled by AMIVAS (US), LLC Due to Lack of Assurance of Sterility: Air filter failed...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact AMIVAS (US), LLC directly.
Affected Products
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.
Quantity: 292 cartons
Why Was This Recalled?
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About AMIVAS (US), LLC
AMIVAS (US), LLC has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report