Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianap
Summary
The FDA issued a Class II for Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, by Leadiant Biosciences, Inc.. Reason: Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus..
Details
Source
Drug Recall
External ID
D-0327-2023
Action Date
2023-02-22
Status
Terminated
Category
drug
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
Lot/Code Info: Lot#: 1203A, Exp. 5/11/2024
Quantity Affected: 31,879 vials
Reason for Recall
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Distribution
Nationwide USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-03
Company
Gaithersburg, MD
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 73 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Leadiant Biosciences, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Leadiant Biosciences, Inc. have FDA actions?
This is the only FDA action we have on record for Leadiant Biosciences, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0327-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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