FDA recall D-1144-2017

Product

New Kopi Jantan Tradisional Natural Herbs Coffee, packaged in 13 gram red packets, and each box contains 25 packets, Made in Malaysia, USA Distributor: Bestherbscoffee LLC (USA), Email: bestherbscoffee@yahoo.com

Reason for recall

Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.

Distribution

Recalling firm only distributed to 2 consignees in TX; however recalling firm reported that product is then distributed U.S. nationwide to consumers via individuals or internet

Key facts

Status

Terminated

Initiation date

2017-07-17

Report date

2017-09-20

Termination date

2018-08-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Arlington, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1144-2017