Three Companies Recall Immune Globulin Products

A total of 28 lots have been recalled because of a high rate of allergic reactions.

Several manufacturers of immune globulin have voluntarily withdrawn intravenous and subcutaneous products because of a higher rate of allergic/hypersensitivity type reactions. Hypersensitivity and anaphylactic reactions are a known risk with immune globulin products.

In all, 28 lots have recalled, impacting four different products from three different manufacturers. Click here for a list of the lots affected by this recall.

Impacted are three lots of Octagram 10% manufactured by Octapharma. It is an intravenous immune globulin to treat chronic immune thrombocytopenic purpura (ITP) in adults and dermatomyositis (DM) in adults. ITP is a blood disorder characterized by a decrease in the number of platelets in the blood, which can lead to bruising, bleeding gums, and internal bleeding. DM is an inflammatory disease marked by muscle weakness and skin rash. The product's first approval was in 2004.

Two of CSL Behring’s products have been impacted by the recall as well, including six lots of Privigen, an intravenous form of immune globulin, and four lots of Hizentra, a subcutaneous form of immune globulin.

Privigen is used to treat patients with primary immune deficiency who are 15 years of age or older and chronic inflammatory demyelinating polyneuropathy (CIDP), a neurological disorder that leads to weakness and impaired sensory function in the legs and arms. Its first approval was in 2017 for CIDP.

Hizentra is used to treat primary immune deficiency in adults and pediatric patients 2 years of age and older and as a maintenance therapy in adults with CIDP. Its first approval was in 2018 for CIDP.

Also involved in the recall are 15 lots of Gamunex-C, developed by Grifols. This is an intravenous and subcutaneous immune globulin to treat ITP, primary immune deficiency, and CIDP. Its first approval was in 2010 for primary immune deficiency.