Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Fra...
FDA Recall #D-0571-2025 — Class II — July 30, 2025
Product Description
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
Reason for Recall
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Recalling Firm
Cardinal Health Inc. — Dublin, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
6 units
Distribution
Nationwide Within the U.S.
Code Information
Lot: 3617756, Expires: 12/31/2025.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated