Over 88,000 Anti-Inflammatory Injections Recalled

Genentech Inc is voluntarily recalling 88,620 prefilled syringes containing Xolair (omalizumab) for failing to meet stability specifications, according to the July 14, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects Xolair single-dose prefilled syringes, 150 mg/1 mL (NDC 50242-215-01), from lots 3352758 (Exp. 8/21) and 3352759 (Exp. 8/21). The injections, a product of France, were manufactured by Genentech Inc, a member of the Roche Group, South San Francisco, CA, and distributed throughout the United States.

Genentech initiated the recall June 9, 2021. On July 6, 2021, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Xolair is a prescription anti-inflammatory injection used to treat asthma, nasal polyps, and chronic idiopathic urticaria.