May 24, 2011 - Globe All Wellness, LLC has been informed by the Food and Drug Administration (FDA) that one of the company’s weight loss dietary supplements that was sold by a seller that was not authorized by Globe All Wellness, LLC to sell the product contains an undeclared drug ingredient. FDA lab analyses of this dietary supplement was found to contain undeclared Sibutramine. The FDA has not approved Sibutramine; therefore the safety and effectiveness of this product is unknown.
All lots of the following dietary supplement products are being recalled:
Slim Xtreme™ Herbal Slimming Capsule 30 Capsules/BottleThe products listed above were sold and distributed nationwide via the internet and at the company’s headquarters in Hollywood, Florida. The FDA advises that this 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, arrhythmias or stroke.
No illnesses or injuries have been reported to Globe All Wellness, LLC to date in connection with this product.
With abundance of caution, Globe All Wellness, LLC is voluntarily recalling all lots of SLIM XTREME™ from the market as a precautionary measure.
This recall does not affect the sales and distribution of Globe All Wellness, LLC’s other products such as SLIM XTREME GOLD™ or GELSLIM™.
Globe All Wellness, LLC has taken this voluntary action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. Globe All Wellness, LLC is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.