AMIVAS (US), LLC is recalling 292 cartons of Artesunate for Injection (110 mg/vial) because an air filter failed an integrity test during manufacturing. This failure leads to a lack of assurance that the injected medication is sterile. The recall affects both the 2x2 and 4x4 pack sizes distributed to hospitals and medical centers nationwide. No incidents or injuries have been reported in connection with this issue.
A lack of sterility in an injectable drug can cause serious or life-threatening infections. Because the air filter failed its integrity test, there is no guarantee that the drug was protected from environmental contaminants during the filling process.
Firm initiated recall via letter to distributors.
Quantity: 292 cartons. The 2x2 pack contains 2 vials of artesunate and 2 vials of diluent. The 4x4 pack contains 4 vials of artesunate and 4 vials of diluent.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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