AMPHOTERICIN B Recall D-0327-2023
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
AMPHOTERICIN B Recall D-0327-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0327-2023 |
| Event ID | 91643 |
| Brand | ABELCET |
| Generic Name | AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- |
| Manufacturer | AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- |
| Original Package? | 1 |
| Active Substance | AMPHOTERICIN B DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide USA |
| Quantity | 31,879 vials |
| Recall Reason | Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus. |
| Drug Classification | Class II |
| Drug Code Info | 20230222 |
| Product NDC | 57665-101 |
| Product NUI | N0000175510 N0000175498 M0017172 |
| Pharma Class (EPC) | Lipid-based Polyene Antifungal [EPC] |
| Pharma Class (CS) | Polyenes [CS] |
| Recall Initiation Date | 20230203 |
| Report Date | 20230222 |
| Classification Date | 20230215 |
| Address | 9841 Washingtonian Blvd Ste 500 Gaithersburg, MD 20878-7352 United States |
| Recalling Firm | Leadiant Biosciences, Inc. |
| Initial Notification | |
| Unique Ingredient Identifier | 7XU7A7DROE U86ZGC74V5 |
| Drug Application Number | NDA050724 |
| Structured Product Labeling (SPL ID) | ef1a50cb-a1a1-2602-e053-2a95a90a0e4a |
| Structured Product Labeling (SPL Set ID) | 5587db37-f21a-4a39-a319-e1077032ced9 |
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