Frederick, MD, United States
AMIVAS (US), LLC recalls
1 recall recorded since 2018, most recently on 27 September 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 27 September 2021
- Terminated
- 27 June 2023
- Reason
- Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0002-2022
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.