Amivas recalls artesunate injection due to lack of sterility assurance
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.
Use caution until it’s fixed
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/35837-amivas-recalls-artesunate-injection-due-to-lack-of-sterility-assurance.
Source Summary by GovInfoNow · govinfonow.com/recall/35837-amivas-recalls-artesunate-injection-due-to-lack-of-sterility-assurance · Updated August 18, 2026 · FDA enforcement record: FDA #D-0002-2022
Cite this page
“Amivas recalls artesunate injection due to lack of sterility assurance.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35837-amivas-recalls-artesunate-injection-due-to-lack-of-sterility-assurance. Based on FDA recall #D-0002-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0002-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Amivas- Category
Drug
What to do — step by step
Check Product Details
Look for the lot numbers AR479E01, AR479E02, or AR479E03 with expiration dates up to November 2022 on the vial packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #D-0002-2022 (September 27, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0002-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.