Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Reason
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Classification
Class II
Status
Ongoing
Lot
Lot: 3630004, Expires: 10/31/2025.
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.