CLASS II Drug recall · Reported 13 Oct 2021 · FDA Enforcement Report
Artesunate for Injection, 110 mg/vial recalled by Amivas (us)
Amivas (us) is recalling Artesunate for Injection, 110 mg/vial, distributed nationwide in the US. The recall was initiated on 27 Sep 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0002-2022
- FDA event ID
- 88772
- Recalling firm
- Amivas (us), Frederick, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Sep 2021
- FDA classified
- 5 Oct 2021
- Reported
- 13 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 27 Sep 2021 | Recall initiated by company | |
| 5 Oct 2021 | Classified by FDA | +8 days |
| 13 Oct 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Is Artesunate for Injection, 110 mg/vial recalled?
Yes. Amivas (us) recalled Artesunate for Injection, 110 mg/vial on 27 Sep 2021. The recall is Class II and its status is Terminated. Recall number D-0002-2022.
Why was it recalled?
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.