FDA Recall D-1144-2017
BESTHERBS COFFEE LLC · Arlington, TX
Class I — life-threatening Terminated 389 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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: [email protected]
Reason for recall
Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.
Recall record
- Recall number
D-1144-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- 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
- Recall initiated
- 2017-07-17
- Classified by FDA Center
- 2017-09-12
- FDA published
- 2017-09-20
- Terminated
- 2018-08-10
- Recalling firm
- BESTHERBS COFFEE LLC
- Firm location
- Arlington, TX