Anonymous
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Anonymous
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Novartis Pharmaceuticals has received a Form 483 noting a failure of its changeover inspection to ensure products from previous packaging operations are removed. A customer complaint for the blood pressure medication Diovan HCT (valsartan/hydrochlorothiazide) reported finding tablets with the wrong dose of the drug in a sealed bottle, according to the form. The Suffern, N.Y., facility’s investigation concluded that inappropriate clearance of a down bottle bin from the previous run was one of the most likely root causes.