New Kopi Jantan Tradisional Natural Herbs Coffee…

Date

Sept. 20, 2017

Risk class

Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)

Status

Terminated

Filed by

Bestherbs Coffee LLC

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

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

Distribution pattern

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

Quantity

6,250 packets

Codes and lots

UPC 557205060083 ,Exp 5/24/18

Recall started

July 17, 2017

Recall number

D-1144-2017

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-1144-2017. The agency record governs; check it and the company before acting.