BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
FDA Recall #D-0540-2025 — Class II — April 21, 2025
Product Description
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
Reason for Recall
CGMP Deviations; potential temperature excursions due to transit delays
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office — Richmond, VA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3 Vials
Distribution
Within the U.S - OH, VA, FL.
Code Information
Lot: YK4W, Expiration date: 4/30/2029
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated