Drug product
GINSENG KIANPI PIL, 60 capsules, PRODUCT OF KWEILIN DRUG MANUFACTORY
D-0329-2015
Product summary
- Firm
- One and Zen
- Event
- Event 69836
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38 bottles
- Official record key
drug-enforcement:D-0329-2015
Official wording
Reason: 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.
Code information: All lots
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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.