US Drug Recall Register
Class II · Moderate risk Terminated Initiated Feb 3, 2023 (4 years ago)

Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

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

Recalling firm
Leadiant Biosciences, Inc.
NDC code
57665-101-41
Origin
MD, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0327-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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