April 08, 2025
On March 21, 2025, Grifols Therapeutics LLC withdrew one additional lot of Gamunex-C® (immune globulin injection [human], 10% caprylate/chromatography purified) 40G vials to the consumer level due to an increased rate of reported hypersensitivity reactions with the affected lot. Previously, Grifols had withdrawn one lot on Feb. 20, 2025, for the same reason. Gamunex-C is an immune globulin solution indicated for treating primary humoral immunodeficiency (PI) in patients two years of age or older, idiopathic thrombocytopenic purpura (ITP) in adults and children and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. Hypersensitivity and anaphylactic reactions are listed in the warnings and precautions section for the prescribing information; however, this lot may pose a higher risk for these reactions. To read more about the recall, see here.
Last updated: April 08, 2025