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

FDA recall notice · announced February 22, 2023 · Leadiant Biosciences

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide USA
Lot/code information: Lot#: 1203A, Exp. 5/11/2024
Quantity: 31,879 vials
Status: Terminated
Products in this recall event:
- 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 2087 (D-0327-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.