Medications & Supplements/Prescription Drugs

Abelcet Injection Recalled for Lack of Sterility Assurance

Agency Publication Date: February 15, 2023

Summary

Leadiant Biosciences, Inc. is recalling Abelcet (Amphotericin B Lipid Complex) Injection (5 mg/mL, 100 mg vial) due to concerns about the sterility of the product. Approximately 31,879 vials are affected after a test during the manufacturing process showed the presence of a bacterium called Cupriavidus pauculus. No incidents or injuries have been reported to date regarding this issue.

Risk

Administering an injectable medication that lacks sterility assurance can lead to serious, potentially life-threatening infections as the drug is delivered directly into the patient's bloodstream.

What You Should Do

This recall affects Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vials, labeled with NDC 57665-101-41 and identified by Lot 1203A with an expiration date of 5/11/2024.
Hospitals, specialty pharmacies, and healthcare providers should immediately check their inventory for the affected lot number printed on the vial or carton labels.
Stop using the recalled product. Contact Leadiant Biosciences, Inc. or your distributor to arrange for the return of any remaining vials from lot 1203A.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) with any additional questions.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Abelcet (Amphotericin B Lipid Complex) Injection (100 mg vial)

Variants: 5 mg/mL, 100 mg vial, Rx only

Lot Numbers:

1203A (Exp. 5/11/2024)

NDC:

57665-101-41

Manufactured by Exelead, Inc., Indianapolis, IN 46268; Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91643

Status: Resolved

Manufacturer: Leadiant Biosciences, Inc.

Sold By: Specialty pharmacies; Hospitals; Healthcare providers

Manufactured In: United States

Units Affected: 31,879 vials

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vials, labeled with NDC 57665-101-41 and identified by Lot 1203A with an expiration date of 5/11/2024.

Hospitals, specialty pharmacies, and healthcare providers should immediately check their inventory for the affected lot number printed on the vial or carton labels.

Stop using the recalled product. Contact Leadiant Biosciences, Inc. or your distributor to arrange for the return of any remaining vials from lot 1203A.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) with any additional questions.