Reported Feb 22, 2023 · Terminated

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

Leadiant Biosciences, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Leadiant Biosciences, Inc. · 9841 Washingtonian Blvd Ste 500 · Gaithersburg, MD · 20878-7352

Is this the product you have?

  • 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
Lot codes and dates
    • Lot#: 1203A
    • Exp. 5/11/2024
Amount recalled
31,879 vials

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 30, 2024 · Data as of Sep 19, 8:08 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.