ISSUE: Nature’s Universe notified the public it is recalling all lots of Thinogenics product sold prior to February 6, 2014 to the user level after FDA analysis revealed that the affected 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 Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010, due to increased risk of seizures, heart attacks, arrhythmia and strokes.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 Thinogenics product an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
BACKGROUND: These products are used as weight loss aids and are packaged as capsules in bottles. The recalled product contains 30 capsules per bottle. Nature’s Universe distributed these products worldwide to customers via internet sales through their website.
RECOMMENDATION: Nature’s Universe is notifying its customers by letter. Customers are advised to immediately discontinue use of Thinogenics product purchased prior to February 6, 2014 and should return the product immediately to Nature’s Universe.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form 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
[04/09/2014 - Press Release - Nature’s Universe]