Reported Feb 22, 2023 · Terminated
Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc.,…
Leadiant Biosciences, Inc.
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: Leadiant Biosciences, Inc. · 9841 Washingtonian Blvd Ste 500 · Gaithersburg, MD · 20878-7352
Is this the product you have?
- Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268; Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 57665-101-41
- Lot codes and dates
Lot#: 1203AExp. 5/11/2024
- Amount recalled
- 31,879 vials
Where it was sold
- Nationwide
Why it was recalled
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
This product could cause temporary or reversible health problems — stop using it.
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