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