Recall -- Firm Press Release
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J & H Besta Corp. Issues a Voluntary Nationwide Recall of Slim- 30 Herb Supplement Found to Contain an Undeclared Drug Ingredient
FOR IMMEDIATE RELEASE - July 16, 2010 - J & H Besta Corp. of Hicksville, NY, has been informed by the Food and Drug Administration (FDA) that 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.
FDA advises that 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.
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.
J & H Besta Corp. is taking this voluntary action because of the concern for the health and safety of consumers. The company has discontinued distribution of this affected product lot. It sincerely regrets any inconvenience to our customers.
Consumers should not consume the Slim-30 Herb Supplement and should return it immediately to the place of purchase for a full refund. Consumers with questions should contact Jason Wang at 516-735-1436, Monday through Friday, 10:00 am to 5:30 pm, EDT.
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 [1-800-FDA-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 fax [1-800-FDA-0178].
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.