D-0540-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- July 30, 2025
- Initiation Date
- April 21, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 Vials
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
Distribution Pattern
Within the U.S - OH, VA, FL.
Code Information
Lot: YK4W, Expiration date: 4/30/2029