PlainRecalls
FDA Drug Critical Class I Terminated

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: [email protected]

Reported: September 20, 2017 Initiated: July 17, 2017 #D-1144-2017

Product Description

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: [email protected]

Reason for Recall

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

Details

Recalling Firm
BESTHERBS COFFEE LLC
Units Affected
6,250 packets
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
Location
Arlington, TX

Frequently Asked Questions

What product was recalled?
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: [email protected]. Recalled by BESTHERBS COFFEE LLC. Units affected: 6,250 packets.
Why was this product recalled?
Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 20, 2017. Severity: Critical. Recall number: D-1144-2017.