Godi International, Corp., located in South Florida is announcing a recall of Fruta Planta weight loss dietary supplements because the products contain sibutramine, an undeclared drug ingredient.
The 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, Corp in connection with these products.
Sibutramine is an FDA approved drug used as an appetite suppressant for weight loss. This poses a potential 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.
All lots of the Fruta Planta and Reduce Weight Fruta Planta Dietary Supplement Products are being recalled.
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 wants all consumers to know that 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.
Godi International, Corp. has taken this voluntary action because it is committed to providing accurate information to all customers and is concerned for the health and safety of all users of Fruta Planta. Godi International, Corp, is working with the FDA in the recall process. We sincerely regret any inconvenience the recall may cause customers.
Customers are advised to immediately discontinue use and discard the above products in a sealed container where children and animals cannot gain access to it. Customers with questions may contact us 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 or by fax.
- Online:www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail
- to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
