LIQUID SODIUM BICARB 45X-4 BO/CS

Description of Event or Problem

AN ADMINISTRATIVE ASSISTANT CONTACTED CUSTOMER SERVICE TO REPORT THAT PATIENT HAD JUST BEEN RELEASED FROM THE HOSPITAL. WHEN THE CUSTOMER SERVICE REPRESENTATIVE ASKED HER WHY THE PATIENT WAS IN THE HOSPITAL, SHE STATED IT WAS BECAUSE THE PATIENT WAS IN FLUID OVERLOAD BECAUSE OF THE BICARB-PRODUCT NUMBER 14487308-CL024-0. NO ADDITIONAL ORDER WAS NEEDED AND NO RGA IS NEEDED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).