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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