One Lot of Xembify Withdrawn

On Jan. 13, 2025, Grifols Therapeutics LLC withdrew one lot to the consumer level for Xembify® (immune globulin subcutaneous, human-klhw) 20% 4G vial due to an increased rate of reported hypersensitivity reactions with the affected lot. Xembify is an immune globulin solution indicated for treating primary humoral immunodeficiency (PI) in patients two years of age or older. Hypersensitivity and anaphylactic reactions are listed in the warning and precautions section for the prescribing information; however, this lot may pose a higher risk for these reactions. For prescribing details, see here.