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

Reason: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

Code information: Lot: 3617756, Expires: 12/31/2025.

Distribution pattern: Nationwide Within the U.S.