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
Reason for recall: Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Recall initiated: 20230203
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated