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Joyful Slim Herb Supplement : Recall-Undeclared Drug Ingredient

Thu, 07/22/2010 - 11:30am
U.S. Food & Drug Administration

Audience: Consumers

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].

[07/22/2010 - Press Release - J&H Besta Corp]

    

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