URGENT: BIOLOGIC RECALL INFORMATION
Initiated by :  Grifols Therapeutics LLC Event Id :  181 Event Date :  08-22-2019

Therapy	Gamunex™ NDC Number Lot Number Size Packaging Expiration Date 13533-800-24 B1GLC01592 20g 200 mL Bottle 12-06-2021
Reason	As a precautionary measure, this voluntary withdrawal is being conducted due to a higher rate of allergic/hypersensitivity type reactions, a small number of which were considered serious and involved the possible risk of a life threatening situation. Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with IVIG products.
Action	Please examine your stock immediately to determine if you have any of the above mentioned lot. If you have product from this lot, cease use of the product immediately. Return the affected lot to the 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.