LYNCHBURG, Va.—Last year, C.B. Fleet Company voluntarily recalled its over-the-counter products Fleet® Phospho-soda® and Fleet® Phospho-soda® EZ-Prep® Bowel Cleansing System after the U.S. Food and Drug Administration (FDA) issued a safety alert stating that oral sodium-phosphates bowel-cleansing solutions should be available by prescription only.
However, the News & Advance is reporting that C.B. Fleet says its products are safe and has collected thousands of cases of the products and is considering ways to put the drugs back on the market.
Chris McDaniel, chief scientific officer for C.B. Fleet, said the company continues to assert that the recalled drugs are safe when used as directed. C.B. Fleet wants to sell them again if it can ensure that they would be used correctly. He said that oral sodium phosphate formulas are safe for bowel cleansing, pointing out that the FDA still allows several brands to be used on a prescription basis. C.B. Fleet has had some discussions with the FDA about the possibility of making Phospho-soda products available under prescription.
Thirty-eight federal lawsuits alleging that the drugs C.B. Fleet recalled have caused serious kidney damage were consolidated last week in one federal court in the Northern District of Ohio.
