ISSUE: FDA lab analysis of Slim-30 Herb Supplement distributed by the company was found to contain undeclared N-Desmethyl Sibutramine and traces of Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved this product, therefore the safety and effectiveness of the product is unknown. This product poses 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.
BACKGROUND: Slim-30 Herb Supplement is marketed as a Natural Herb for Weight Loss. Slim-30 Herb Supplement is packaged in plastic bottles containing 30 capsules per bottle and bears UPC 8 31457 005009 2. The affected lot/code being recalled is 032009. The product was sold to distributors and retail stores nationwide and China and via internet sales. No illnesses or injuries have been reported to the company to date in connection with this product.
RECOMMENDATION: Consumers should not consume the Slim-30 Herb Supplement and should return it immediately to the place of purchase for a full refund.
Report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch “Download Forms” page, to address on the pre-addressed form
Fax: 1-800-FDA-0178[07/16/2010 – Press Release– J & H Besta Corp.]