Recalls / Class II
Class IID-1358-2016
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.
- Affected lot / code info
- All lots
Why it was recalled
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Recalling firm
- Firm
- Murray International Trading Co., Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 908 Dean St, Brooklyn, New York 11238-3204
Distribution
- Quantity
- 97 boxes
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-04-20
- FDA classified
- 2016-07-11
- Posted by FDA
- 2016-07-20
- Terminated
- 2018-06-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1358-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.