Class II
Terminated
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
- Company
- Leadiant Biosciences, Inc
- Recall Initiated
- February 3, 2023
- Posted
- February 22, 2023
- Recall Number
- D-0327-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 31,879 vials
- Firm Location
- Gaithersburg, MD, United States
Reason for Recall
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Distribution
Nationwide USA
Lot / Code Info
Lot#: 1203A, Exp. 5/11/2024
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