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Recall Observatory FDA recall evidence

Drug product

THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Count Bottles, THINOGENICS LLC, Nashville, TN 37203 USA.

D-1594-2014

April 09, 2014

Class I

Product summary

Firm
Nature's Universe
Event
Event 68455
Status
Terminated
Classification
Class I
Quantity
Unknown
Official record key
drug-enforcement:D-1594-2014

Official wording

Reason: Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.

Code information: None Available. All lots distributed prior to 02/06/2014 are being recalled.

Distribution pattern: U.S. Nationwide and Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.