SmartLipo365 has announced a voluntary recall of all lots of Smart Lipo 800mg, 900mg, and 950mg capsules. The recall is prompted by a Food and Drug Administration (FDA) analysis which found that Smart Lipo contained undeclared sibutramine, desmethylsibutramine, and phenolphthalein. Smart Lipo capsules are marketed as a dietary supplement and sold in store and via the Internet.
Sibutramine is an appetite suppressant that was pulled from the market in October 2010. It is known to increase blood pressure and/or pulse rate in some patients. It may also present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Phenolphthalein, an ingredient previously used in over-the-counter laxatives, is currently unapproved after concerns of carcinogenicity. Some safety risks associated with phenolphthalein include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.
SmartLipo365 is alerting its distributors and customers via email and letter and will discontinue distribution of Smart Lipo. Consumers are recommended to discontinue use of these products.
For more information call (972) 757-8136 or visit FDA.gov.