Product: 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.
Recall initiated: 20160420
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated