Drug recall D-0327-2023

Class II Terminated reported Feb 22, 2023

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.

Lots and codes

Lot#: 1203A, Exp. 5/11/2024

Recall details

Recalling firm
Leadiant Biosciences, Inc., Gaithersburg, MD
Quantity
31,879 vials
Distribution
Nationwide USA
Type
Voluntary: Firm initiated
Recall initiated
February 3, 2023
Terminated
September 30, 2024