Drug product
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
D-0540-2025
Product summary
- Event
- Event 97110
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3 Vials
- Official record key
drug-enforcement:D-0540-2025
Official wording
Reason: CGMP Deviations; potential temperature excursions due to transit delays
Code information: Lot: YK4W, Expiration date: 4/30/2029
Distribution pattern: Within the U.S - OH, VA, FL.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations