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news.PRock Marketing, an authorized US distributor of the supplement Authentic Formula Fruta Planta, has recalled the supplement as it was found to contain 15.4mg of Sibutramine, a controlled substance that was withdrawn from the market in October 2010 for safety reasons.
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The company’s decision follows the Food and Drug Administration (FDA)verdict that the weight loss dietary supplements sold and marketed contains an undeclared drug ingredient.
All lots of the Fruta Planta and Reduced Weight Fruta Planta dietary supplement products are being recalled.
These products pose a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.