Grifols Therapuetics withdraws one lot of Xembify

Grifols Therapeutics is initiating a voluntary withdrawal of one lot of XEMBIFY, 20% 4G VIAL. 

Therapy 

XEMBIFY®
NDC Number: 13533-810-20   
Lot Number:  B01J107803    
Size: 4g    
Packaging: 20 mL    
Expiration Date: 10-29-2027

Reason

This is to inform you that Grifols Therapeutics is initiating a voluntary withdrawal of one lot of XEMBIFY, 20% 4G VIAL as detailed below.

Grifols is committed to providing the highest quality medicines in the market. This voluntary withdrawal is being conducted due to the potential for an increased rate of allergic/hypersensitivity type reactions associated with this specific lot. Although Grifols has not received any reports of allergic/hypersensitivity type reactions related to this lot as of January 13, 2025, it is being withdrawn as a precautionary measure following an increased rate of reported hypersensitivity reactions in a separate lot made from the same source material. Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products.

Action

Please examine your stock immediately to determine if you have any of the above-mentioned lots on hand. If you have product from this lot, cease use of the product immediately.

Return the affected product 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.