FDA MedWatch - Ultimate Body Tox PRO: Recall - Undeclared Drug Ingredient

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Ultimate Body Tox PRO: Recall - Undeclared Drug Ingredient

AUDIENCE: Consumer

ISSUE: Ultimate Body–Tox is voluntarily recalling all lots of Ultimate Body Tox PRO capsules to the consumer level. FDA analyses of this product found it to contain undeclared sibutramine. Sibutramine is a controlled substance that was removed from the U.S. market in October 2010 for safety reasons. The presence of sibutramine in Ultimate Body Tox PRO renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

The product 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, irregular heartbeat, or stroke.

BACKGROUND: Ultimate Body Tox PRO is marketed as a dietary supplement for weight loss and is packaged in 45 count bottles.  All lots are included in this recall. The products listed above were sold and distributed nationwide via the internet and in NC.

RECOMMENDATION: Ultimate Body–Tox is notifying its distributors and customers by phone and is arranging for return of all recalled products. Consumers, distributors, and retailers that have Ultimate Body Tox PRO should stop using and/or distributing the product, and return to place of purchase.

Consumers with questions may contact the company at 910-633-3596 Monday through Friday from 9:00am to 4:00pm EST for instructions on the return process. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm531233.htm