Dietary Supplement Recalled for Undeclared Sibutramine and Lack of Approval
Nature's Universe is recalling ThinoGenics dietary supplements because they contain undeclared sibutramine and were marketed without FDA approval.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Nature's Universe is recalling ThinoGenics, Weight Loss Made Easy! Dietary Supplement, 30 Count Bottles. The recall is being conducted because the product contains undeclared sibutramine and was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The recalled product was distributed in the U.S. nationwide and in Canada. All lots distributed prior to February 6, 2014, are included in this recall. No specific lot numbers are available.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Count Bottles, THINOGENICS LLC, Nashville, TN 37203 USA.
- Manufacturer
- Nature's Universe
- Category
- Drug — Dietary Supplement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- None Available. All lots distributed prior to 02/06/2014 are being recalled.
Distribution
Distributed nationwide across the United States.
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