# FDA recall D-0002-2022

> **AMIVAS (US), LLC** · Class II · drug recall initiated 2021-09-27.

## 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 sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-10), Rx only, Mfg for: Amivas, LLC, 1209 Orange St., Wilmington, Delaware 19801.

## Reason for recall

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.

## Key facts

- **Recall number:** D-0002-2022
- **Recalling firm:** AMIVAS (US), LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-09-27
- **Report date:** 2021-10-13
- **Termination date:** 2023-06-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Frederick, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0002-2022

## Citation

> AI Analytics. FDA recall D-0002-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0002-2022. Source: US FDA. Licensed CC0.

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