Guest guest Posted October 14, 2003 Report Share Posted October 14, 2003 Recall of Immune Globulin Intravenous (Human) 10% Solvent/Detergent Treated, Gamimune (Bayer Corporation) Posted: 10/14/2003, Recall Date: 10/3/2003 This document is available on the internet at http://www.fda.gov/cber/recalls.htm#gam **************************************************************** DATE RECALL INITIATED: October 3, 2003 LOT NUMBERS / EXPIRATION DATES: 28N33W1 5/14/2006 26N34C1 5/17/2006 26N35V1 5/23/2006 26N36V1 5/23/2006 26N37J1 7/24/2006 26N37P1 7/30/2006 26N37R1 8/1/2006 MANUFACTURER: Bayer Corporation Clayton, NC REASON: These lots exhibit an increased rate of adverse event reports associated with allergic reactions. These reported reactions are identified in the package insert as the type of reactions one would expect with intravenous immunoglobulin administration. Consignees have been asked to contact the manufacturer to arrange for product return. ______________________________________________ Responsibility for the content of this message lies strictly with the original author, and is not necessarily endorsed by or the opinion of the Research Institute. Quote Link to comment Share on other sites More sharing options...
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