Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Reason Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
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