Svelte 30 Nutritional Consultants has been informed by the Food and Drug Administration (FDA) that a sample of Svelte 30 orange & gray capsule was collected and tested by FDA in January 2011.
The capsules tested positive for sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved Svelte 30 orange & gray capsules as drugs; therefore the safety and effectiveness of this product is unknown.
FDA advises that these products may 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.
Svelte 30 orange & gray capsules are marketed as a "natural herb for weight loss". Svelte 30 Herb Supplement is packaged in plastic bottles containing 30 capsules per bottle and bears UPC #’s from 04-3000 to 04-5999. Were MFD: 10/22/2010 with EXP: 10/21/2012. This lot would have been available for sale on January 03, 2011.
The lots from 04-3000 to 04-5999 is the only one subject to recall and it was not distributed through www.svelte.com.
The company discontinued total distribution. It sincerely regrets any inconvenience to its customers.
The product was sold directly to individual customers in their Kissimmee, Florida sales office.
No illnesses or injuries have been reported to the company to date in connection with this product. This recall is being conducted with the knowledge of the FDA.
Svelte 30 Nutritional Consultants is taking this voluntary action because they are committed to the health and safety of our customers and to the quality of their select brand. They are working diligently to make available an appropriate Natural Herbal replacement product manufactured in the USA for all of their affected customers. They are moving forward with new suppliers for their new custom formula.
Consumers should not consume Svelte 30 orange & gray capsules Herb Supplement and should return it immediately to the place of purchase for a refund. Consumers with questions should contact Pedro A Lopez at 407-350-5940, Monday - Friday, 10:00 am - 5:00 pm, EDT.
Any adverse reactions experienced with the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/Safety/MedWatch/default.htm.