Recall -- Firm Press Release
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Nature’s Universe Issues Voluntary Worldwide Recall of All Thinogenics Products Sold Prior to 02/06/2014 Due to the Presence of Undeclared Sibutramine
FOR IMMEDIATE RELEASE - April 9, 2014 - Nature’s Universe is voluntarily recalling all lots of old Thinogenics product (product sold prior to February 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 Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes).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. Nature’s Universe was completely unaware that the Old Product contained sibutramine. Beginning February 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 February 6, 2014 is being recalled. Nature’s Universe distributed these products worldwide to customers via internet sales through their website at www.shopnaturesuniverse.com and www.easy2loseweight.com .
Nature’s Universe is notifying its customers by letter. Customers are advised to immediately discontinue use of the Thinogenics Old Product purchased prior to February 6, 2014 and should return the product immediately to Nature’s Universe, 2817 West End Avenue, Nashville, Tennessee 37203 for the new, replacement product which has been reformulated and does not contain sibutramine.
Consumers with questions regarding this recall should contact Nature’s Universe customer service at 1-800-405-7817 Monday – Friday 8am to 6pm CT or via e-mail at firstname.lastname@example.org. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm (http://www.fda.gov/medwatch/report.htm)
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm (http://www.fda.gov/MedWatch/getforms.htm) or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.