Issue: FDA lab analysis of this herb supplement was found to contain the undeclared drug, desmethyl sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss. 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.
Background: This product is marketed as a Natural Herb for Weight Loss, is packaged in plastic bottles containing 30 capsules per bottle and bears UPC 8 97966 00200 7. The affected lot/code being recalled is 101408. The product was sold to distributors and retail stores nationwide and via internet sales. The company has discontinued distribution of Joyful Slim.
Recommendations: Consumers should not consume the product and should return it immediately to the place of purchase for a full refund. Any adverse reactions experienced with the use of this product may be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page], by mail [to address on the pre-addressed form] or by fax [1-800-FDA-0178].
Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm219983.htm