AMIVAS (US), LLC: Drug Recall
Recall #D-0002-2022 · 09/27/2021
Class II: Risk
Recall Details
- Recall Number
- D-0002-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- AMIVAS (US), LLC
- Status
- Terminated
- Date Initiated
- 09/27/2021
- Location
- Frederick, MD, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 292 cartons
Reason for Recall
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Product Description
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.
Distribution Pattern
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.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.