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Recall Observatory FDA recall evidence

Drug product

GINSENG KIANPI PIL, 60 capsules, PRODUCT OF KWEILIN DRUG MANUFACTORY

D-0329-2015

November 20, 2014

Class II

Product summary

Firm
One and Zen
Event
Event 69836
Status
Terminated
Classification
Class II
Quantity
38 bottles
Official record key
drug-enforcement:D-0329-2015

Official wording

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.

Code information: All lots

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.