Grifols Withdraws Four Lots of Gamunex-C 10%
- By BSTQ Staff
Grifols Therapeutics has initiated a voluntary withdrawal of four lots of Gamunex-C 10%. The voluntary withdrawal is being conducted as a precautionary measure due to an increased rate of allergic/hypersensitivity type reactions associated with these specific lots. A small number of the 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.
The affected lots of Gamunex-C 10% are:
• Lot Number B03J086043; Material Number 730806; Expiration Date 08/31/2027; NDC 13533-800-24
• Lot Number B03J077152; Material Number 729688; Expiration Date 10/10/2027; NDC 13533-800-24
• Lot Number B03J079503; Material Number 730807; Expiration Date 08/16/2027; NDC 13533-800-40
• Lot Number B01J100623; Material Number 730807; Expiration Date 10/03/2027; NDC 13533-800-40
Examine your stock immediately to determine if any of the above-mentioned lots are on hand. If there is any product from these lots, cease use of the product immediately.
For any questions concerning return of the product, contact US Customer Service via email at [email protected] or call (800) 243-4153.