April 18, 2014
Nature's Universe Issues Voluntary Worldwide Recall of All Thinogenics Products Due to the Presence of Undeclared Sibutramine
The Missouri Department of Health and Senior Services received information regarding a recall of old Thinogenics product (product sold prior to Feb. 6, 2014, hereinafter the "Old Product") to the user level after FDA analysis revealed that the Old Product contained undeclared sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). This ingredient made the Old Product an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Nature's Universe was advised that the FDA received seven complaints about the Old Product. Beginning Feb. 13, 2014, as a result of notification from the FDA, Nature's Universe began selling a new, reformulated Thinogenics that does not contain sibutramine (hereinafter referred to as the "New Product").
These products are used as weight loss aids and are packaged as capsules in bottles. The New Product (which is not being recalled) can be identified because each bottle contains 45 capsules (see attached label), where the Old Product contains 30 capsules per bottle (see attached label). Any of the remaining Old Product sold prior to Feb. 6, 2014 is being recalled.
The full recall including a of products can be found at: http://www.fda.gov/Safety/Recalls/ucm393876.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.