Recalls / Class II
Class IID-0327-2023
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
- Affected lot / code info
- Lot#: 1203A, Exp. 5/11/2024
Why it was recalled
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Recalling firm
- Firm
- Leadiant Biosciences, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 9841 Washingtonian Blvd Ste 500, N/A, Gaithersburg, Maryland 20878-7352
Distribution
- Quantity
- 31,879 vials
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2023-02-03
- FDA classified
- 2023-02-15
- Posted by FDA
- 2023-02-22
- Terminated
- 2024-09-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0327-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.