D-0329-2015 Class II Terminated
FDA drug recall D-0329-2015 was initiated by One and Zen on November 20, 2014 and is designated Class II. 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. The recall status is terminated (terminated March 23, 2015). Affected quantity: 38 bottles.
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