Bacai Recalls Tainted Herbal Diet Supplement
Bacai is issuing a voluntary recall at the retail and consumer level of one lot of LiteFit USA capsules, an herbal weight loss dietary supplement. Bacai distributed LiteFit USA on behalf of its manufacturer Global Herb, after being provided certification of analysis reporting compliance with US health and safety standards. However, FDA laboratory analysis found a sample containing sibutramine, a Schedule IV substance removed from the market due to safety concerns.
The affected 30-count bottles are from Lot #13165 with an expiration date of May 2017, and were distributed worldwide by wholesalers, retailers, and through the internet between June 26, 2013 and March 27, 2014.
Sibutramine was voluntarily withdrawn from the market in October 2010 following evidence supporting potentially serious cardiovascular adverse effects. Sibutramine may pose a significant risk for patients with prior coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Bacai is notifying its distributors and customers by mail to arrange for return of all recalled products sold in the U.S. Those in possession of the affected lots should stop using the product and return them their place of purchase.
For more information call (714) 775-0050 or read the FDA Safety Alert.