FDA-Drug2023-02-22Class II
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
Leadiant Biosciences, Inc.
Hazard
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Sold states
Nationwide USA
Affected count
31,879 vials
Manufactured in
9841 Washingtonian Blvd Ste 500, N/A, Gaithersburg, MD, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0327-2023Don't want to check this manually?
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