25 de agosto del 2025
On Aug. 8, 2025, Grifols Therapeutics LLC withdrew two lots of Gamunex-C® (immune globulin injection [human], 10% caprylate/chromatography purified) 20G vials to the consumer level due to an increased rate of reported hypersensitivity reactions with the affected lots. This follows similar withdrawals on Feb. 19 and March 21, 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 of the prescribing information; however, these lots may pose a higher risk for these reactions. For more details, see here.
Última actualización: 31 de julio del 2025