PNS Notification from Sedgwick
Initiated by :  ADMA Biologics Inc Event Id :  221 Event Date :  02-18-2025

Therapy	Bivigam NDC Number Lot Number Size Packaging Expiration Date 69800-6503-1 321524 10g 100 ml vial 07-01-2027
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 examine your stock immediately to determine if you have any vials from the above-mentioned lot on hand. 2) If you have product from this lot, cease us of the product immediately. 3) Return the affected product to the point of purchase to receive replacement product.
Other Information	If you have any technical or clinical questions, please contact ADMA Customer Service at Customerservice@ADMAbio.com or call 1-800-458-4244.