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Two Lots of Gamimune N (Immune Globulin) Recalled Due To Tampering RESEARCH TRIANGLE PARK, NC and LEVERKUSEN, GERMANY -- March 18, 2002 -- Bayer Corporation announced the discovery of an apparent product tampering with Gamimune® N, Immune Globulin Intravenous (Human), 10%, Solvent/Detergent Treated. Although the product is distributed nationwide, Bayer has received no reports of any adverse reactions relating to the apparent tampering. Use of the adulterated product poses a serious health risk to the patient. Bayer notified federal authorities and initiated a voluntary recall of two lots containing these vials -- lot 648X078, recalled Feb. 1, 2002, and lot 648X062, recalled March 14, 2002. Health care professionals, distributors, pharmacists or patients in possession of vials from these lots should not use them and should report them to Bayer Clinical Communications, 1-800-288-8371. To date, an analysis of the recalled material from both lots suggests that, after product left Bayer's control, the vial overseals of a small portion of the returned product were tampered with. Additionally, Bayer determined that the returned vials with damaged overseals (13 vials) have unexpectedly low protein concentration, an elevated chloride level, and the presence of bacteria. To date, Bayer views these to be isolated incidents and several hundred vials have been returned. "Bayer is shocked and angered by this situation. Tampering in this fashion means that patients who are taking this medication for any number of immune deficiency problems will not receive the intended effect of the product," said Dr. Gunnar Riemann, general manager of Bayer's Biological Products Business Group. "The company's commitment to product quality and patient safety are paramount. Bayer has shared all available information with the appropriate regulatory authorities and has been assured they are pursuing this matter aggressively." "The company recognizes its responsibility to patients. We are taking a number of steps to help health care providers ensure the integrity of our products and any other intravenous product and quickly recognize any future tampering," Dr. Riemann added. Bayer has consulted with the Immune Deficiency Foundation (IDF) on an appropriate strategy for approaching the situation, and the two entities are working together to implement solutions. Bayer will be taking the following steps moving forward: * Educating customers on how to identify products that appear to be altered in any way * Developing enhanced tamper-resistant packaging for all Bayer biological products * Convening a multi-disciplinary industry meeting to discuss the prevention of future occurrences Bayer is asking all customers who handle vials of Gamimune N to look for the following signs that product may have been mishandled or subjected to tampering: * Inconsistency between the lot number indicated on the box and the lot number indicated on the vial contained in the box * Evidence of overseal damage such as dimpling, buckling, puncture, or any other indications the seal has been compromised * Absence of the vial flip top * Presence of white or other colored precipitate (flakes or foreign matter) in the vials * Cloudiness or discoloration of the solution (it should appear colorless to pale yellow) * In the event someone identifies suspicious product, they should immediately contact Bayer Clinical Communications, 1-800-288-8371, to provide the information and receive further instructions. Bayer will do everything in its power to keep the community well informed and provide leadership in attempting to prevent future incidents in the marketplace. SOURCE Bayer Biological Products E-mail this page to a friend or colleague! To print, use this version