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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.

Iovate Health Sciences U.S.A., Inc. Adds Hydroxycut-Branded Product Universal Product Codes to its Voluntary Nationwide Recall

Contact:
Jamie Moss
201-493-1027

FOR IMMEDIATE RELEASE -- (May 7, 2009) -- Iovate Health Sciences USA, Inc. of Blasdell, New York and Ontario, Canada announced today that it is adding Universal Product Codes (UPCs) with respect to the Hydroxycut-branded products sold in the United States and subject to the voluntary recall.  These additions all involve additional packages and sizes of products previously referenced.   

The UPC numbers being added to the May 1 list are as follows:

631656800265    Hydroxycut Hardcore 8 fl. oz. Grape Explosion
631656800210    Hydroxycut Hardcore 8 fl. oz. Triple Wildberry
631656001501    Hydroxycut 280ct-3 Pak Kit *Discontinued*    
631656001563    Hydroxycut 280ct-6 Pak Kit *Discontinued*    
631656000658    Hydroxycut 100ct-6 month supply (7 bottles+ 4 free) Kit    
631656600896    Hydroxycut 2x60ct Club Pack US Kit   
631656000672    Hydroxycut 100ct-1 month supply (1 bottle+1 free) Kit *Discontinued*    
631656874693    Hydroxycut 58 cap 12-pack Target US Kit *Discontinued*
631656000665    Hydroxycut 100ct-3 month supply (4 bottles+2 free) Kit *Discontinued*
631656002362    Hydroxycut Sachet Twin Pack US Kit    
631656860498    Hydroxycut Instant Weight Loss Shot 12 x 2oz - Wild berry US Kit    
631656660623    Hydroxycut Hardcore Shredded Stack Kit120ct
631656500585    Hydroxycut 60 Rapid Release Caplets

Iovate initiated a voluntary recall when it became aware that the U.S. Food and Drug Administration’s assessment of 23 reports about consumers having experienced liver-related problems, as well as a small number of published case reports, was different from Iovate’s analysis.  On May 1, 2009, the FDA issued an advisory which states that, “Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk.”  The number of adverse event reports described by the FDA is small relative to the many millions of people who have used Hydroxycut products over the 7 years referenced by the FDA.  Iovate’s own assessment of the potential risk associated with the use of these products differs from that expressed by the Agency.  Every product marketed by Iovate is evaluated during its development for the safety of its individual ingredients.  Additionally, independent third-party experts from the leading independent scientific firm specializing in ingredient assessment, toxicology and product safety for the nutritional and pharmaceutical industry review the safety of Iovate’s ingredients and formulas before products are introduced in the marketplace.  Only after this external review is completed does Iovate release a formula.

However, out of an abundance of caution and because consumer safety is Iovate’s top priority, Iovate is voluntarily recalling these Hydroxycut-branded products.

Consumers with questions about the recall can visit www.hydroxycutinformation.com for more information.  Consumers can also contact the company by calling 1-877-468-2835 Monday through Friday between 9 am and 5 pm Eastern Daylight Time.

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