FDAFDA · Food and drugs·Recall number D-1206-2019
Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.
Published April 24, 2019 · Recall initiated: April 5, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Brian P. Richardson
- Distributor
- Nationwide in the USA
- Lot
- All Lots labeled with EXP 13 10 2020
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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