FDA recall D-0540-2025
Mckesson Medical-Surgical Inc. Corporate Office · Class II · drug
Product
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
Within the U.S - OH, VA, FL.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-04-21
- Report date
- 2025-07-30
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Richmond, VA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0540-2025