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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- 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.
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