Recall
FDAHealthApril 21, 2025

Mckesson Medical-Surgical Inc. Corporate Office — BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.

⚠️ CGMP Deviations; potential temperature excursions due to transit delays

Is this relevant to me?

Geography
OH, VA, FL
Source agency
FDA
Category
Health
Published
April 21, 2025

Within the U.S - OH, VA, FL.

What's affected?

Product
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
Lot code
YK4W

Additional details

Lot: YK4W, Expiration date: 4/30/2029

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 3 Vials.

View original FDA notice →

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