Drug product
FUQINGSONG RELIEF CREAM (Flucinonide Ointment), packaged in 50-count individually labeled pieces Net Wt. 0.32oz (10g) within a box, MANUFACTURED BY: TIANJIN MAEDICAL & PHARMACEUTICAL CO., LTD. ADDREST: 96 BAWAEI ROAD, HEDONG COUNTY, TIANJIN CITY, remaining labeling contains Chinese characters.
D-1358-2016
Product summary
- Event
- Event 74017
- Status
- Terminated
- Classification
- Class II
- Quantity
- 97 boxes
- Official record key
drug-enforcement:D-1358-2016
Official wording
Reason: Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Code information: All lots
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.