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March 25, 2021- The Alpha-1 Foundation received this Patient Notification System from Grifols Therapeutics LLC  

PNS Notification from Stericycle
Initiated by :  Grifols Therapeutics LLC
Event Id :  198
Event Date :  03-23-2021

 

Therapy
Gamunex™
NDC Number Lot Number Size Packaging Expiration Date
13533-800-24 A3GLE01462 20g 200 ML 10-19-2023
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 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