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Bowel Prep Kit Withdrawn for S&E

03/19/2010

Federal Register Notice: FDA has determined that Halflytely and Bisacodyl Tablets Bowel Prep Kit (polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution and 4 bisacodyl delayed release tablets, 5 mg (20-mg bisacodyl)) was withdrawn from sale for reasons of safety or effectiveness. The agency will not accept or approve ANDAs for bowel prep kits containing PEG-3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution and 4 bisacodyl delayed release tablets, 5 mg. To view this notice, click here.

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