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Recall Observatory FDA recall evidence

Drug product

Super Fat Burning Bomb Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL

D-1374-2014

January 24, 2014

Class I

Product summary

Firm
MyNicNaxs, Inc.
Event
Event 67471
Status
Terminated
Classification
Class I
Quantity
unknown
Official record key
drug-enforcement:D-1374-2014

Official wording

Reason: Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Phenolphthalein and N-desmethylsibutramine

Code information: ALL LOTS

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Phenolphthalein and N-desmethylsibutramine