FDA recall D-1350-2016

Murray International Trading Co., Inc. · Class II · drug

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.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2016-04-20
Report date: 2016-07-20
Termination date: 2018-06-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brooklyn, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1350-2016