Thursday, June 28, 2007

Voluntary Recall of One Lot of Fluotic® (sodium fluoride) 20 mg tablets and Notice of Product Discontinuation

From Health Canada:
This letter is to inform you that sanofi-aventis Canada Inc., with agreement from Health Canada, has undertaken a voluntary recall of one lot of Fluotic® (sodium fluoride) 20 mg tablets, bottle of 100: lot number 8034613 (expiry date: September 2008). This voluntary recall is intended to address a quality issue. In in-vitro tests, the disintegration time of some tested samples in gastric fluid-like solution was faster than usual. Although the product is not likely to cause any adverse health consequences to the patient, there is potential risk that an early disintegration of sodium fluoride in the gastric environment may increase the risk of gastric toxicity such as gastric irritation, risk of bleeding or gastric ulcer. ...more

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