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Recall Observatory FDA recall evidence

Drug product

Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1.

D-0722-2016

September 29, 2015

Class I

Product summary

Firm
Fit Firm and Fabulous
Event
Event 72874
Status
Terminated
Classification
Class I
Quantity
3000 bottles
Official record key
drug-enforcement:D-0722-2016

Official wording

Reason: Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug.

Code information: Lot #: 05/02/2015 to 05/01/2017

Distribution pattern: Nationwide in the U.S.A. via the website.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug.