Drug product
Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.
D-1206-2019
Product summary
- Event
- Event 82584
- Status
- Terminated
- Classification
- Class I
- Quantity
- 6000 packages
- Official record key
drug-enforcement:D-1206-2019
Official wording
Reason: 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.
Code information: All Lots labeled with EXP 13 10 2020
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
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.