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.
Reason for recall: Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Recall initiated: 20160420
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated