# FDA recall D-0329-2015

> **One and Zen** · Class II · drug recall initiated 2014-11-20.

## Product

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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0329-2015
- **Recalling firm:** One and Zen
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-11-20
- **Report date:** 2015-01-07
- **Termination date:** 2015-03-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Albuquerque, NM, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0329-2015

## Citation

> AI Analytics. FDA recall D-0329-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0329-2015. Source: US FDA. Licensed CC0.

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