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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Confidence Inc. Issues a Voluntary Nationwide Recall in the United States and Canada of One Lot of METABOSLIM Apple Cider Vinegar brand dietary supplement found to contain an Undeclared Drug Ingredient

 

Contact:
Confidence Inc.
516-767-1870

 

FOR IMMEDIATE RELEASE --Port Washington, NY -- August 17, 2007 --- Confidence Inc. of Port Washington, NY, is recalling one lot of METABOSLIMTM Apple Cider Vinegar brand dietary supplement, lot number 3001006, EXP. 102009 and UPC CODE: 92483 00102 because it contains the undeclared drug ingredient sibutramine. This lot was primarily sold in Canada. The product is sold in a plastic bottle with white and red labeling and contains 60 gelatin capsules.

The Company has been informed by the Food and Drug Administration (FDA) that lab analysis of METABOSLIMTM samples found that the product contains undeclared sibutramine, an FDA approved drug used as an appetite suppressant for weight loss. The FDA has not approved METABOSLIMTM as a drug; therefore the safety and effectiveness of this product is unknown.

FDA advises that this 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.

No illnesses or injuries have been reported to the company to date in connection with this product.

Confidence, Inc. has taken this voluntary action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. Confidence Inc. is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.

Consumers should return any unused METABOSLIMTM for a refund of the full purchase price or price for the unused portion, to the Company's address in Port Washington, NY, or contact Jim Chao at 516-767-1870 or email jim@confidenceusa.com to receive further instructions for returning the product or with any questions.

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