The FDA says product information sheets, a launch presentation and a customer letter for Abbott’s Prism HBsAg (antibody to hepatitis B surface antigen [mouse monoclonal IgM]) and Prism HBcore (hepatitis B virus core antigen [E. coli, [recombinant]) were false and misleading because they failed to reveal facts on important risks associated with the products.
From the May 01, 2007 Issue of MM+M - Medical Marketing and Media