FDA-Drug2025-08-13Class II
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
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
4 units
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0572-2025Don't want to check this manually?
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