Shaping Beauty, Inc. of Southampton, Pennsylvania, has been informed by the U.S. Food and Drug Administration (FDA) that a weight-loss dietary supplement it sold and marketed contains an undeclared drug ingredient.
FDA lab analyses of the defective drugs distributed by Shaping Beauty were found to contain undeclared Sibutramine (the active ingredient in Meridia) used as an appetite suppressant for weight loss. The FDA has not approved these products as drugs; therefore, the safety and efficacy of this product is unknown. This drug recall includes all lots of Celerite Slimming Capsules dietary supplement products.
The defective drugs were sold and distributed nationwide via the internet at www.shapingbeauty.com.
The FDA advises that these products pose a threat to consumers because the products contain Sibutramine. Drug side effects of Sibutramine include that it substantially increases 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.
No illnesses or injuries have been reported to the company, to date, in connection with this product.
The FDA is advising consumers to return the defective drug to the company’s address in Southampton, Pennsylvania. Shaping Beauty can be reached, Monday through Friday, 9:00 a.m. to 5:30 p.m., toll-free at 1-800-728-2850.
Any adverse reactions experienced with the use of this product should also 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 via the MedWatch website.