FDA Investigating Reports of Allergic Reactions Associated With Certain IGIV/IGSC Products

The Food and Drug Administration is investigating an increase in reports of allergic and hypersensitivity reactions linked to specific lots of immune globulin intravenous (IGIV) and immune globulin subcutaneous (IGSC) products. Some reported reactions were severe, requiring treatment with epinephrine or steroids, or hospitalization.

The affected products include Asceniv lot #239825 (expiration Aug. 31, 2027,) and Bivigam lot #237452 (expiration Oct. 31, 2027), both manufactured by ADMA Biologics.

FDA advised health care facilities to immediately examine their inventories for vials from these lots and to cease use if any are identified. Facilities with questions should contact the manufacturer directly.

FDA continues to monitor the safety of immune globulin products and will share updates as more information becomes available.