Abelcet Injection recalled over sterility concerns

Recall date

February 3, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Leadiant Biosciences, Inc. recalls Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indiana…

Recall number

D-0327-2023

FDA classification

Class II

Brand / firm

Leadiant Biosciences, Inc.

Sold / distributed

Nationwide USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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