Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
Reason
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Classification
Class II
Status
Ongoing
Lot
Lot: 3617756, Expires: 12/31/2025.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Cardinal Health Inc. — Class II Recall | MedicineWatch US