FDAFDA · Food and drugs·Recall number D-0327-2023
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
Published February 22, 2023 · Recall initiated: February 3, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Leadiant Biosciences, Inc.
- Distributor
- Nationwide USA
- Lot
- Lot#: 1203A, Exp. 5/11/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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