According to a notice by the U.S. Food and Drug Administration issued on December 18, Dallas, Texas-based SmartLipo365 voluntarily recalled the 800, 900, and 950 mg capsules of Smart Lipo due to the discovery of undeclared ingredients including sibutramine, phenolphthalein, and desmethylsibutramine.
Sibutramine may increase blood pressure and pulse rates, and it may put consumers with coronary artery disease, arrhythmia, stroke, or congestive heart failure at risk of serious complications and death. Phenolphthalein may be carcinogenic and is not approved to be marketed in the United States. The undeclared ingredients, according to FDA, render the products unapproved.
The recalled products were sold in bottles of 30 capsules and were distributed nationwide through the manufacturer’s website, smartlipo365.com.
The manufacturer is currently notifying its consumers and is set to discontinue the distribution of the product. Retailers and distributors are urged to also discontinue the products.
If you have been affected by this product and are planning to build a case against the negligent manufacturer, make sure to seek the help of our product liability lawyers at Habush Habush & Rottier S.C. ®. Call our Wisconsin offices today at (414) 271-0900.