Amivas recalls artesunate injection vials (110 mg/vial) because air filter failure during manufacturing led to potential contamination. Products were sold with specific lot numbers and expiration dates.
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Amivas is recalling artesunate injection vials that may not be sterile due to a manufacturing issue with the air filter. This could lead to infections if the medication is used.
The air filter in the manufacturing process failed after an integrity test, which means the medication might not be sterile. This could cause infections if the injection is used.
People who have been prescribed artesunate injections for malaria treatment in the U.S. are affected. Those using the medication for medical purposes are at risk of infection if the product is not sterile.
Check for the product code 73607-001-01 in the vial packaging. The lot numbers AR479E01, AR479E02, or AR479E03 with expiration dates up to November 2022 are affected.
Look for the lot numbers AR479E01, AR479E02, or AR479E03 with expiration dates up to November 2022 on the vial packaging.
The air filter in the manufacturing process failed after an integrity test, leading to a lack of sterility assurance in the artesunate injection.
Check the lot numbers on the vial packaging. If it matches AR479E01, AR479E02, or AR479E03 with an expiration date up to November 2022, contact your healthcare provider for guidance.
The official recall notice does not specify a deadline for action.
We’ve drafted a message you can send Amivas to request your refund or repair — edit it as you like.
Subject: Recall D-0002-2022 — Amivas Amivas Hello, I own a Amivas that is covered by recall D-0002-2022 from Amivas. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
