PRock Marketing, LLC of Kissimmee, Florida, an authorized United States distributor of the Authentic Formula Fruta Planta has been informed by the U.S. Food and Drug Administration (FDA) that these weight loss dietary supplements contain an undeclared drug ingredient. All lots of <"http://www.yourlawyer.com/practice_areas/defective_drugs">Fruta Planta and Reduce Weight Fruta Planta, a single product marketed under two brand names, are involved.
The FDA lab analysis of the dietary supplements found the Authentic Formula Fruta Planta to contain 15.4 mg of Sibutramine, a controlled substance that was withdrawn from the market in October 2010 for safety reasons.
No illnesses or injuries have been reported to the company, to date, in connection with the recalled supplements; however, the FDA has received multiple reports of adverse events associated with the use of Fruta Planta and Reduce Weight Fruta Planta, including several cardiac events and one death.
The FDA advises against taking ALL formulas of Reduce Weight Fruta Planta/Reduce Weight products. 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. Sibutramine may also interact in life-threatening ways with other medications a consumer may be taking.
All lots of the Fruta Planta and Reduced Weight Fruta Planta dietary supplement products are being recalled. All these products contain the active pharmaceutical ingredient Sibutramine. Fruta Planta and Reduce Weight Fruta Planta is available in 30-capsule boxes:
â€¢ Fruta Planta: 30 capsules/box
â€¢ Reduce Weight Fruta Planta: 30 capsules/box; 30 capsules/bottle
â€¢ Reduce Weight Fruta Planta: 30 capsules/pink box
â€¢ Reduce Weight Fruta Planta: 30 capsules/box with GMP sticker
â€¢ Reduce Weight Fruta Planta: 30 capsules/box
â€¢ Reduce Weight 30 capsules/box
Fruta Planta and Reduce Weight Fruta Planta are sold online at www.frutaplanta.com and other online retailers and can also be found in some retail locations. PRock Marketing, LLC wants all consumers to know that there is NO SAFE formula on the U.S. market and that all versions of Fruta Planta contain Sibutramine. All versions of the formula are UNSAFE and should not be purchased from any source.
Consumers should stop using this product immediately and throw it away in a sealed container where children and animals cannot gain access to it or return the recalled product to the firm. Consumers with questions may contact frutaplanta.com Monday through Friday 10:00 a.m. – 4:30 p.m. at 1.877.225.1009, Eastern Standard Time.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax: Online at www.fda.gov/medwatch/report.htm; regular mail by using a postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm, mailed to the address on the pre-addressed form; or by fax to 1.800.FDA.0178.