Reported Oct 13, 2021 · Terminated
Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01)…
Amivas (us), LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AMIVAS (US), LLC · 100 Tuscanney Dr Suiteb2 · Frederick, MD · 21702
Is this the product you have?
- 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 forAmivas, LLC, 1209 Orange St., Wilmington, Delaware 19801
- Lot codes and dates
- Manufacturer Lot Numbers
AR479E01exp. date 11/03/2022AR479E02exp. date 11/09/2022AR479E03exp. date 11/16/2022Cardinal
- Health Packaging Solutions Lot Numbers7507001 and 7508001
- Manufacturer Lot Numbers
- Amount recalled
- 292 cartons
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
This product could cause temporary or reversible health problems — stop using it.
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