The Recall Desk
CriticalFDA (Drugs)·D-1594-2014·Announced 2014-09-24

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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
Hazard

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.

Related recalls

Same hazard · undeclared drug

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