Leadiant Biosciences, Inc.: Drug Recall
Recall #D-0327-2023 · 02/03/2023
Class II: Risk
Recall Details
- Recall Number
- D-0327-2023
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Leadiant Biosciences, Inc.
- Status
- Terminated
- Date Initiated
- 02/03/2023
- Location
- Gaithersburg, MD, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31,879 vials
Reason for Recall
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Product Description
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
Distribution Pattern
Nationwide USA
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.