PNS Notification from Sedgwick
Initiated by :  Grifols Therapeutics LLC Event Id :  232 Event Date :  08-14-2025

Therapy	Gamunex™ NDC Number Lot Number Size Packaging Expiration Date 13533-800-24 B01J093362 20g 200 mL 12-02-2027 13533-800-24 B01J094362 20g 200 mL 12-08-2027
Reason	This is to inform you that Grifols Therapeutics is initiating a voluntary withdrawal of two lots of Gamunex-C, 20G Vial, as detailed below. Grifols is committed to providing the highest quality medicines in the market. This voluntary withdrawal is being conducted as a precautionary measure due to an increased rate of allergic/hypersensitivity type reactions associated with these specific lots. A small number of the reactions were considered medically significant. Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products. This withdrawal is being conducted with the knowledge of the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research.
Action	Please examine your stock immediately to determine if you have any of the above-mentioned lots on hand. If you have product from these lots, cease use of the product immediately. Return the affected product to point of purchase to receive replacement product.
Other Information	If you have any technical or clinical questions, please contact US Clinical Communications at (800) 520-2807.