Drug & medication recalls Moderate risk

GINSENG KIANPI PIL recalled over undeclared dexamethasone

Recall date
November 20, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
One and Zen recalls GINSENG KIANPI PIL, 60 capsules, PRODUCT OF KWEILIN DRUG MANUFACTORY
Recall number
D-0329-2015
FDA classification
Class II
Brand / firm
One and Zen
Sold / distributed
Nationwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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