Fleet® Phospho-Soda® Recall

On December 11, 2008 the U.S. Food and Drug Administration (“FDA”) issued a safety alert for oral sodium phosphate bowel cleansing solutions stating the risks and dangers pose extreme health risks to consumers.  As a result, the C.B. Fleet Company immediately issued a voluntary recall for all over the counter oral sodium bowel cleansing solutions including the Fleet® Phospho-soda® oral Saline Laxative and the Fleet® Phospho-soda®  EZ-PREP Bowel Cleansing System. 

Dr. Janet Woodcock, Director of the FDA’s Center for Evaluation and Research cited growing concerns about “serious adverse events associated with the use of oral sodium phosphates” including irreversible acute kidney injury to patients with no pre-existing health factors.   

Oral sodium bowel cleansing solutions like the Fleet® Phospho-soda® are used to cleanse the bowel prior to a colonoscopy or bowel surgery.  Unfortunately the use of the solutions, even one time, can cause serious dehydration causing irreversible kidney damage like acute phosphate nephropathy.  Sadly, several cases have lead to death.