On December 11, 2008, the U.S. Food & Drug Administration (FDA) in association with the manufacturer of Fleet Phospho-soda, C.B. Fleet Company initiated a nationwide recall of the popular bowel cleansing solution.
In the manufacturers press release, they stated …
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.
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 bbowel cleansing and contact their physician for alternatives if their physician has recommended
their use for this purpose.
FDA Video: Stronger Warnings for Bowel Cleansing Agents
In April 2009, the U.S. Food & Drug Administration issued a warning on Bowel Cleansing Agents and the development of acute phosphate nephropathy, a rare but serious type of kidney injury. Included below is a video issued from the FDA regarding the warning.
Read the Full Transcript: Stronger Warnings for Bowel Cleansing Agents