D-0329-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 7, 2015
- Initiation Date
- November 20, 2014
- Termination Date
- March 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38 bottles
Product Description
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 Pattern
Nationwide
Code Information
All lots