Hydroxycut FDA Recall

FOR IMMEDIATE RELEASE -- (May 1, 2009) -- Iovate Health Sciences USA, Inc. of Blasdell, New York and Ontario, Canada announced today that it is voluntarily recalling Hydroxycut branded products sold in the United States.

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 thirdparty 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.

The recalled products are sold in multiple-count caplet and capsule boxes and bottles. The FDA advisory states that, “Consumers who have these products are urged to stop using them.” Iovate is working with the FDA and retailers to ensure that these products are quickly and effectively removed from the market. For product refunds, consumers are directed to return their product directly to the location where it was purchased. Consumers with questions about the advisory or recall can visit www.hydroxycutinformation.com for more information. Consumers can also contact the company by calling 1-877-468-2835 between 9 am and 5 pm Eastern Standard time.
 

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Davis & Crump is now handling claims for individuals who have suffered liver damage or other side effects from the use of a Hydroxycut product.  Davis & Crump is experienced in pharmaceutical product liability cases and settlements.   If you or a loved one has suffered liver damage or other side effects from the use of a Hydroxycut product, contact us at 1-800-277-0300 or send us an email at info@daviscrump.com.