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

FDA Recall #D-0329-2015 — Class II — November 20, 2014

Recall #D-0329-2015 Date: November 20, 2014 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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.

Recalling Firm

One and Zen — Albuquerque, NM

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

38 bottles

Distribution

Nationwide

Code Information

All lots

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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