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

Recall Number: D-0327-2023

Firm: Leadiant Biosciences, Inc.

Classification: Class II

Status: Terminated

Report Date: 20230222

Initiation Date: 20230203

Termination Date: 20240930

Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.

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