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.

Recall Number: D-1350-2016

Firm: Murray International Trading Co., Inc.

Classification: Class II

Status: Terminated

Report Date: 20160720

Initiation Date: 20160420

Termination Date: 20180614

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.

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.