3 FDA recalls mention Omalizumab. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Omalizumab.
Reason CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
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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