Abelcet recall: Sterility Concern
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
Why was Abelcet recalled?
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot#: 1203A, Exp. 5/11/2024
- 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
- Recalling firm
- Leadiant Biosciences, Inc.
- Quantity
- 31,879 vials
- Distribution
- Nationwide USA
- Recall date
- February 22, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)