FDA-Drug2025-08-13Class II
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
Cardinal Health Inc.
Hazard
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Sold states
Nationwide Within the U.S.
Affected count
6 units
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0571-2025Don't want to check this manually?
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