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FDARecalled Aug 13, 2025 · #D-0571-2025

Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.

Hazard

Class II — temporary health risk

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Description

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. Classification: Class II Distribution: Nationwide Within the U.S.

Product details

Product
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
Type
Drugs
Manufacturer
Cardinal Health Inc.
Model numbers
3617756
UPCs