Certain Immune Globulin Products Withdrawn Due to Higher Rate of Hypersensitivity Reactions

Several lots of immune globulin products have been voluntarily withdrawn as a precautionary measure due to reports of allergic/hypersensitivity type reactions, some of which were considered medically significant.

The Immune Globulin Intravenous (IGIV) products mentioned in the safety alert include Octagam 10% (Octapharma; Lot # K139B8541, K140A8561, and K139A8561) and Privigen (CSL Behring; Lot # P100287718, P100371288, P100366291, P100356115, P100349929, and P100287723).

Octagam 10% is indicated for the treatment of chronic immune thrombocytopenic purpura and dermatomyositis. Privigen is indicated for the treatment of primary humoral immunodeficiency (PI) in patients 3 years of age and older, chronic immune thrombocytopenia purpura in patients 15 years of age and older, and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

The Immune Globulin Subcutaneous (IGSC) products include Hizentra (CSL Behring; Lot # P100369103, P100369102, P100343632, and P100340460) and Gamunex-C (Grifols Biologicals, Inc; Lot # A1GLE01642, A1GLE01582, A4GLE01512, A3GLE01432, A4GKE01092, A4GKE01012, A1GKF00042, A1GKF00032, A1GKF00022, A1GKF00052, A1GLE01602, A3GLE01462, A4GLE01482, A1GLE01542, and A1GLE01532).

Hizentra is indicated for the treatment of PI in patients 2 years of age and older, and for maintenance therapy in adults with CIDP. Gamunex-C is approved for the treatment of PI in patients 2 years of age and older, idiopathic thrombocytopenic purpura in adults and children, and CIDP in adults.

Individuals are advised to discontinue use of any of the affected products immediately and return it to the point of purchase. Additional information can be found on the FDA’s website.

Reference

Voluntary lot withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for increased reports of allergic/hypersensitivity reactions. News release. US Food and Drug Administration. Accessed March 8, 2022. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/voluntary-lot-withdrawals-immune-globulin-intravenous-igiv-and-immune-globulin-subcutaneous-igsc