PNS Notification from Sedgwick
Initiated by :  ADMA Biologics Inc Event Id :  223 Event Date :  03-04-2025

Therapy	Bivigam NDC Number Lot Number Size Packaging Expiration Date 69800-6503-1 321724 10g 100 ml vial 08-31-2027
Reason	This is to inform you that ADMA Biologics is initiating a voluntary withdrawal of one lot of BIVIGAM, 10% 10g vial as detailed below. ADMA Biologics is committed to providing the highest quality medicines in the market. This voluntary withdrawal is being conducted due to the potential for an increased rate of allergic/hypersensitivity type reactions associated with this specific lot. Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products.
Action	1) Please check all product labels against the list of affected lot numbers. 2) Do not take this product. Return affected recalled lots to the point of purchase to receive replacement product. 3) Contact your physician if you have medical questions.
Other Information	If you have any technical or clinical questions, please contact ADMA Customer Service at Customerservice@ADMAbio.com or call 1-888-458-4244.