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Bayer Recalls 2nd Lot of Gamimune N

Cheryl A. Thompson

The Food and Drug Administration (FDA) reported yesterday that Bayer Corp. is recalling vials of Gamimune N 10% from lot 648X062 (expiration date of July 15, 2004). This recall follows the one issued in early February for lot 648X078 (expiration date of Aug. 27, 2004).

According to FDA, the company received one report of a white precipitate in the solution of the intravenous immune globulin product. Initial company-conducted analyses of the vials uncovered "unexpectedly low protein concentration, elevated chloride and the presence of bacteria," FDA said.