Artesunate for Injection Recalled Due to Sterility Assurance Failure
AMIVAS (US), LLC is recalling Artesunate for Injection (110 mg/vial) because an air filter failed post-integrity testing, creating a lack of sterility assurance for the product.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a sterility assurance failure in an injectable pharmaceutical product distributed to hospitals and medical centers nationwide. Loss of sterility assurance in injectable medications poses serious risk of infection and other adverse health consequences, meeting the threshold for Severe classification.
Plain-English summary
AMIVAS (US), LLC is recalling Artesunate for Injection, 110 mg/vial, due to a failure in the manufacturing process. During post-integrity testing, an air filter in the production environment failed, which compromises the assurance that the product meets required sterility standards.
The recalled product was distributed to 3 major distributors who may have further distributed it to various medical centers, hospitals, and hospital pharmacies nationwide in the USA. A total of 292 cartons were distributed. The affected lots are: Manufacturer Lot Numbers AR479E01 (expiration 11/03/2022), AR479E02 (expiration 11/09/2022), and AR479E03 (expiration 11/16/2022), as well as Cardinal Health Packaging Solutions Lot Numbers 7507001 and 7508001.
Healthcare providers who have received this product should stop use and quarantine remaining stock. Patients who have received injections from affected lots should consult their healthcare provider. The manufacturer and FDA are investigating the failure and working to ensure proper handling of the recalled product.
The recalled product
- Product
- 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 ster
- Manufacturer
- AMIVAS (US), LLC
- Category
- Drug — Injectable / Antimalarial
- Hazard
- sterility-assurance-failure
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 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
Distribution
Distributed nationwide across the United States.
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