UltraZx Labs announced a voluntary recall of all lots of UltraZx, dietary supplements promoted for weight loss.
An analysis by the Food and Drug Administration (FDA) found UltraZx to contain undeclared sibutramine and phenolphthalein. Sibutramine is a controlled substance that was pulled from the market in October 2010 for safety concerns. Sibutramine is known to increase blood pressure and/or pulse rate in some patients. It may pose a significant risk in patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Phenolphthalein is a chemical that is not found in any approved drug in the United States. It may present a risk of cancer and may interact with other medications a consumer is taking.
The affected product is supplied as 300mg capsules in 30-count bottles and were distributed from September 2014 through February 2015. The Company is notifying its distributors and customers to arrange for return of all recalled products.
For more information call (305) 904-9393 or visit FDA.gov.