Laboratory analysis conducted by the FDA has confirmed that UltraZx contains sibutramine and phenolphthalein.
Sibutramine is a controlled substance that was removed for safety reasons from the market in October 2010.
UltraZx 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, arrhythmias or stroke.
Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the US and studies have indicated that it presents a cancer causing risk.
So far, the company has not received any reports of adverse events related to this recall.
The product is marketed as a dietary supplement for use as a weight loss aid and is packaged in bottles of thirty (30) capsules of 300mg.
The affected product includes all lots/bottles/packages and was distributed from September 2014 until February 2015.