D-1144-2017 Class I Terminated
FDA drug recall D-1144-2017 was initiated by BESTHERBS COFFEE LLC on July 17, 2017 and is designated Class I. Reason for recall: Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk. The recall status is terminated (terminated August 10, 2018). Affected quantity: 6,250 packets.
Recall Details
- Product Type
- Drugs
- Report Date
- September 20, 2017
- Initiation Date
- July 17, 2017
- Termination Date
- August 10, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,250 packets
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: bestherbscoffee@yahoo.com
Reason for Recall
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
Code Information
UPC 557205060083 ,Exp 5/24/18