FDA Drug recall D-0327-2023
Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268
- FDA Drug
- Class II
- terminated
- Published 2023-02-22
On 2023-02-22 the FDA classified a Class II recall of Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268 by Leadiant Biosciences, citing lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0327-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-02-03 |
| Published | 2023-02-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Leadiant Biosciences |
| Distribution | US |
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
Reason
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Identifiers
| code_info | Lot#: 1203A, Exp. 5/11/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0327-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.