Drug 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
D-1144-2017
Product summary
- Event
- Event 77768
- Status
- Terminated
- Classification
- Class I
- Quantity
- 6,250 packets
- Official record key
drug-enforcement:D-1144-2017
Official wording
Reason: Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.
Code information: UPC 557205060083 ,Exp 5/24/18
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
Derived failure modes
-
Undeclared allergen
undeclared desmethyl carbodenafil and undeclared milk