February 3, 2011
WASHINGTONFDA posted a voluntary recall notice from Godi International Corp., located in South Florida, in which the company stated it is recalling all lots of the Fruta Planta weight loss dietary supplement, after testing by FDA found the presence of sibutramine in the product. Sibutramine was withdrawn from the U.S. market in October 2010 after studies found it could pose a significant cardiac risk. FDA issued a public notification regarding Fruta Planta in December 2010, stating the agency has received several reports of adverse events associated with the use of the product, including one death. One week after FDAs notification, PRock Marketing, the U.S. distributor of the Fruta Planta products, issued a national recall of all lots.
In the case of Godi International, the recalled products include Fruta Planta and Reduce Weight Fruta Planta, sold in 30 capsule boxes; the products were sold and distributed in Columbia and Venezuela, although they could have been brought into the United States. In its recall statement, Godi stated there is NO SAFE formula" of Fruta Planta on the market and all versions of Fruta Planta contain sibutramine [and] are unsafe." The recall is being conducted with FDAs knowledge.
Consumers are urged to discontinue use and destroy the products. Consumers and health care providers can also report any adverse reactions to the products to FDAs MedWatch Adverse Event Reporting program online.
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