D-0572-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- August 13, 2025
- Initiation Date
- July 30, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Reason for Recall
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Distribution Pattern
Nationwide Within the U.S.
Code Information
Lot: 3630004, Expires: 10/31/2025.