D-0540-2025 Class II Ongoing
FDA drug recall D-0540-2025 was initiated by Mckesson Medical-Surgical Inc. Corporate Office on Apr 21, 2025 and is designated Class II. Reason for recall: CGMP Deviations; potential temperature excursions due to transit delays The recall status is ongoing. Affected quantity: 3 Vials.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 30, 2025
- Initiation Date
- Apr 21, 2025
- 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0540-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026