C.B. Fleet Voluntarily Recalls Its Fleet(R) Phospho-soda(R) Products After FDA Safety Alert

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 15 Dec 2008 - 2:00 PDT

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Following the issuance of FDA's Safety Alert on Thursday stating that oral sodium phosphates bowel cleansing solutions should be available by prescription only, C.B. Fleet Company immediately announced a voluntary recall of their over-the-counter products Fleet® Phospho-soda® and Fleet® Phospho-soda® EZ-Prep® Bowel Cleansing System. The voluntary recall is directed to retailers and wholesalers.

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 bowel cleansing and contact their physician for alternatives if their physician has recommended their use for this purpose.

About C.B. Fleet

Founded in 1869 and headquartered in Lynchburg, Virginia, C.B. Fleet is a privately held manufacturer and marketer of personal care and healthcare related products. Well-known for its line of laxative drug products, today C.B. Fleet, doing business under its new Fleet Laboratories name, also markets a diverse range of cosmetic and drug products in 100 countries around the world. Fleet ranks among the top nonprescription drug companies in the U.S.

C.B. Fleet

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