Why it was recalled
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the treatment of male erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Product description
Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.
Lot numbers, UPCs & expiration codes
All Lots labeled with EXP 13 10 2020
Where it was sold
Nationwide in the USA
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-1206-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 5, 2019
- FDA report date
- Apr 24, 2019
- Quantity
- 6000 packages
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Brian P. Richardson
Original FDA data
Every field from FDA enforcement report D-1206-2019, exactly as published.
Show all FDA fields
- City
- Dallas
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 82584
- Address
- 3410 Delafield Ln
- Code information
- All Lots labeled with EXP 13 10 2020
- Postal code
- 75227-5313
- Report date
- Apr 24, 2019
- Product type
- Drugs
- Recall number
- D-1206-2019
- Classification
- Class I
- Recalling firm
- Brian P. Richardson
- Product quantity
- 6000 packages
- Termination date
- Jan 19, 2022
- Reason for recall
- Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the treatment of male erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 5, 2019
- Initial firm notification
- Press Release
- Center classification date
- Apr 22, 2019