Leadiant Biosciences, Inc. recalls Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianap
Recalled February 22, 2023 · FDA recall D-0327-2023 · Leadiant Biosciences
Hazard
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus. · FDA Class II
Units
31,879 vials
Sold at
Nationwide USA
Description
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Product
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
Manufacturer(s)
Leadiant Biosciences, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →