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Bayer Corporation has announced the discovery of apparent product tampering for Gamimune® N, Immune Globulin Intravenous (Human), 10%, Solvent/Detergent Treated (IGIV). IGIV is approved by FDA for use in the treatment of Primary Immune Deficiency, Kawasaki’s disease, Chronic Lymphocytic Leukemia, bone marrow transplantation, Pediatric AIDS, and Immune Thrombocytopenic Purpura.
Bayer received customer reports describing the presence of a white precipitate in the solution in vials of IGIV. Bayer initiated a voluntary recall of two lots of IGIV relating to these vials - lot 648X078, recalled Feb. 1, 2002, and lot 648X062, recalled March 14, 2002. The company’s investigation has to date indicated that distribution of the affected product is limited to the recalled lots. The agency’s investigation of this matter is ongoing.
At this point, it is very important that health care professionals and others who handle or use IGIV nationwide carefully examine all vials of the product to identify potentially tampered product, and to ensure that such product is not used. To facilitate the examination, consumers should access Bayer’s Press Release at
http://www.bayerbiologicals.com/News_Center/Announcements/Gamimune.asp, or their Product Integrity page at http://www.bayerbiologicals.com/News_Center/Announcements/2002/20020320.asp, for information on what to look for in examining the vials. Consumers may also access Bayer’s recall notice at http://www.bayerbiologicals.com/News_Center/Announcements/2002/Recall_attachment_31502.pdf. Use of the tampered product may result in serious health consequences, such as bacterial infection, septic shock, and insufficient dosing of IGIV.
Bayer reports that at this time it has received no reports of adverse reactions relating to the apparent tampering. Bayer also has advised health care professionals, distributors, pharmacists, or patients in possession of vials from these lots not to use them and to report them to Bayer Clinical Communications, 1-800-288-8371.
Specific questions relating to the recalled product should be directed to Bayer at the telephone number listed above. Consumers may also contact the Center for Biologics Evaluation and Research, Office of Communication, Training and Manufacturers Assistance at 1-800-835-4709 or by email at OCTMA@cber.fda.gov.
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