On December 11, 2008 the C.B. Fleet Company voluntarily recalled all their over-the-counter oral sodium phosphate products including Fleet Phospho-soda® and Fleet EZ-Prep™ Bowel Cleansing System.
The recall follows the Food and Drug Administration safety alert on Thursday connecting oral sodium phosphate bowel cleansers to acute phosphate nephropathy. In announcing the recall Fleet said,
The recall decision was made to address FDA’s determination that oral sodium phosphate solutions used for bowel preparation prior to medical procedures such as colonoscopy should only be available by prescription, and consumers should not be using over-the-counter products for bowel cleansing. Since Fleet’s Phospho-soda products are currently labeled and sold as over-the-counter products, Fleet decided voluntarily to remove them from the market as expeditiously as possible to address the FDA’s decision that the products be available by prescription only.
In addition, Fleet recommended that consumers not purchase Fleet’s Phospho-soda for bowel cleansing:
As FDA has recommended that doctors not direct their patients to use these over-the-counter products for bowel cleansing, C.B. Fleet requests that consumers not purchase these products for bowel cleansing and contact their physician for alternatives if their physician has recommended their use for this purpose.
In a letter to health professionals, C.B. Fleet requested that they immediately stop directing patients to use Fleet Phospho-soda or Fleet EZ-Prep for bowel cleansing.