Class II Recall

Leadiant Biosciences, Inc.

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
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Classification
Class II
Status
Terminated
Lot
Lot#: 1203A, Exp. 5/11/2024
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.