Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Recall Number: D-0572-2025
Firm: Cardinal Health Inc.
Classification: Class II
Status: Ongoing
Report Date: 20250813
Initiation Date: 20250730
Termination Date:
Reason for Recall
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Product Description
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55