FDA recall D-0329-2015

One and Zen · Class II · drug

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

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

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