Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by ...
FDA Recall #D-0327-2023 — Class II — February 3, 2023
Product Description
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.
Recalling Firm
Leadiant Biosciences, Inc. — Gaithersburg, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
31,879 vials
Distribution
Nationwide USA
Code Information
Lot#: 1203A, Exp. 5/11/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated