PNS Notification from Sedgwick
 
Initiated by :  Grifols Therapeutics LLC
Event Id :  183
Event Date :  12-17-2019
Therapy
Gamunex™
NDC Number Lot Number Size Packaging Expiration Date
13533-800-71 A4GKD00232 10g 100 mL Bottle 12-13-2019
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 medically significant. 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.