Why it was recalled
Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.
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
Lot numbers, UPCs & expiration codes
UPC 557205060083 ,Exp 5/24/18
Where it was sold
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
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1144-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 17, 2017
- FDA report date
- Sep 20, 2017
- Quantity
- 6,250 packets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- BESTHERBS COFFEE LLC
Original FDA data
Every field from FDA enforcement report D-1144-2017, exactly as published.
Show all FDA fields
- City
- Arlington
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 77768
- Address
- 2420 E Arkansas Ln Ste 216
- Code information
- UPC 557205060083 ,Exp 5/24/18
- Postal code
- 76014-1753
- Report date
- Sep 20, 2017
- Product type
- Drugs
- Recall number
- D-1144-2017
- Classification
- Class I
- Recalling firm
- BESTHERBS COFFEE LLC
- Product quantity
- 6,250 packets
- Termination date
- Aug 10, 2018
- Reason for recall
- Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- 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
- Recall initiation date
- Jul 17, 2017
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 12, 2017