FDA recall D-0327-2023

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.

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2023-02-03

Report date

2023-02-22

Termination date

2024-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gaithersburg, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0327-2023