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Recall Observatory FDA recall evidence

Drug product

Pill for weight reduction, (Japanese Chinese Formula from Japan Hokkaido Cangye Pharmacy Co, Ltd) 400 mg, supplied in 40 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL

D-1375-2014

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-1375-2014

Official wording

Reason: Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein

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 ingredient: Phenolphthalein