PRock Recalls Fruta Planta

KISSIMMEE, Fla.PRock Marketing, the authorized U.S. distributor of Fruta Planta, issued a national recall of all lots of the Fruta Planta and Reduced Weight Fruta Planta dietary supplements, after FDA informed the company the products contain an undeclared drug ingredient. The recall came Dec. 30, one week after FDAs MedWatch site posted a public notification regarding Fruta Planta. The notification stated FDA has received several reports of adverse events associated with the use of the product, including one death, and that 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 Sibutramine was withdrawn from the U.S. market in October 2010 after studies found it could pose a significant cardiac risk.

In its recall statement, PRock Marketing stated there is NO SAFE formula" of Fruta Planta on the U.S. market; All versions of the formula are UNSAFE and should not be purchased from any source," it stated.

Consumers are urged to destroy the products or return them to PRock Marketing. Consumers and health care providers can also report any adverse reactions to the products to FDAs MedWatch Adverse Event Reporting program online. The recall is being conducted with FDAs knowledge.

The product is manufactured by GuangZhou Yanxiang Biotechnology Co. Ltd., Guangzhou, China. On its Fruta Planta website, the company displays a GMP (good manufacturing practice) certificate. The landing page has been updated with a statement regarding the FDA alert, which stated GuangZhou Yanxiang has not been contacted directly by FDA for samples of Fruta Planta to test, and, therefore, at this time we cannot determine if The Authentic Formula Fruta Planta was in fact the product that was consumed." However, the company noted orders are not being taken at this time.