Godi International, Corp. is recalling Fruta Planta weight loss dietary supplements because the products contain Sibutramine an undeclared drug ingredient.
The Food and Drug Administration (FDA) lab analysis of the dietary supplements found the Authentic Formula Fruta Planta to contain 18 mg of Sibutramine. No illnesses or injuries have been reported to Godi International in connection with these products.
Consumer threat
Sibutramine is an FDA approved drug used as an appetite suppressant for weight loss. It poses a potential threat to consumers because Sibutramine is known to cause a substantial increase in 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.
All lots of the Fruta Planta and Reduce Weight Fruta Planta Dietary Supplement Products are being recalled.
Affected products
The following recalled products contain the active pharmaceutical ingredient Sibutramine:
- Fruta Planta; 30 Capsules/Box.
- Reduce Weight Fruta Planta; 30 Capsules/Box with Gold sticker.
- Reduce Weight Fruta Planta; 30 Capsules/Box.
The Products listed above were sold and distributed to Colombia and Venezuela. It is possible that a traveler could purchase the product in Colombia or Venezuela and bring it into the U.S.
Godi International, Corp says there is NO SAFE formula on the 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.
Consumer actions
Customers are advised to discontinue use immediately and discard the above products in a sealed container where children and animals cannot gain access to it. Those with questions may contact Godi Monday through Friday 10:00 am to 5:00 pm, EST at 954-272-6188.
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, using postage-paid, pre-addressed Form FDA 3500 available here and sending it to the address on the pre-addressed form or by fax at 1-800-FDA-0178
