The Recall Desk
SevereFDA (Drugs)·D-0329-2015·Announced 2015-01-07

Ginseng Kianpi Pill Recalled for Undeclared FDA-Approved Drugs

One and Zen is recalling Ginseng Kianpi Pill capsules because FDA analysis found undeclared dexamethasone and cyproheptadine, making the product an unapproved drug.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the presence of undeclared FDA-approved drugs in an unapproved product poses a significant health risk, meeting the criteria for a Severe rating.

Plain-English summary

One and Zen is recalling 38 bottles of Ginseng Kianpi Pill, 60 capsules, manufactured by Kweilin Drug Manufactory. The product was distributed nationwide.

The recall was initiated because FDA analysis found the product contains undeclared dexamethasone and cyproheptadine. These are FDA-approved drugs, which means the product is considered an unapproved drug marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

Consumers who have this product should stop using it and contact One and Zen for further instructions.

The recalled product

Product
GINSENG KIANPI PIL, 60 capsules, PRODUCT OF KWEILIN DRUG MANUFACTORY
Manufacturer
One and Zen
Category
Drug — Unapproved Drug
Hazard
Affected units
38

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · undeclared drug

See all →