Drug 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
D-0327-2023
Product summary
- Event
- Event 91643
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31,879 vials
- Official record key
drug-enforcement:D-0327-2023
Official wording
Reason: Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Code information: Lot#: 1203A, Exp. 5/11/2024
Distribution pattern: Nationwide USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility