Class II · Moderate risk
Artesunate Lyophilized Powder for Injection
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Artesunate for Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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.
Affected NDCs
73607-0001-01
73607-0001-02
73607-0001-10
73607-0001-11
Compare with the code on your package — it is the most precise check available.
Drug: Artesunate
- Recalling firm
- Amivas (US), LLC
- NDC code
- 73607-001-02
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0002-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Artesunate recalls
See all
Class II · Moderate risk
Artesunate active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Other sterility / contamination recalls from 2021
All sterility / contamination recalls
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