PNS Notification from Sedgwick
Initiated by :  Grifols Therapeutics LLC Event Id :  238 Event Date :  08-12-2026

Therapy	GammaKed NDC Number Lot Number Size Packaging Expiration Date 76125-900-20 B13K127733 20g 200mL 10-19-2028
Reason	This is to inform you that Grifols Therapeutics is initiating a voluntary withdrawal of one lot of Gammaked, 20G Vial, as detailed above. 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 this specific lot. A small number of these 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 lot on hand. If you have product from this lot, 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 Kedrion US Medical Info at US_Medicalinfo@Kedrion.com or call (855) 353-7466 (Option 1).