D-1350-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 20, 2016
- Initiation Date
- April 20, 2016
- Termination Date
- June 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 96 bottles
Product Description
Tien Ma Tou Tong Wan (Condensed pills), packaged in 100-count bottles within a box, Kwangchow First Chinese Medicine Factory, Kwangchow, China; 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.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
All lots