Baxter Recalls Gammagard S/D
This article was originally published in The Pink Sheet Daily
Executive Summary
One lot is associated with allergic reactions, FDA says. Two of the adverse events have involved airway events and all reactions have required medical intervention, although none have been life threatening.
You may also be interested in...
Baxter Discontinues Use Of Advate Sales Aids Cited In FDA Warning Letter
CBER takes issue with display of adverse event information and supporting data for statements made in the brochures. FDA says Advate warning letter is unrelated to one issued two weeks earlier for Baxter’s IgIV product Polygam S/D.
Aventis Gammar-P Recall
Aventis Behring is recalling two lots of Gammar-P intravenous 10 gram due to "an increased frequency of non-serious, labeled adverse events associated with allergic reactions," FDA said April 2
“Whistleblower” Suits Should Be Encouraged By Rx Manufacturers, Sen. Grassley Says
Schering-Plough’s Claritin settlement prompts letter from Grassley to Schering and 18 other manufacturers. Educating employees about the False Claims Act and their right to file suit is a “step in the right direction” to address fraud, he says.