Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.
Reported: April 24, 2019 Initiated: April 5, 2019 #D-1206-2019
Product Description
Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.
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.
Details
- Recalling Firm
- Brian P. Richardson
- Units Affected
- 6000 packages
- Distribution
- Nationwide in the USA
- Location
- Dallas, TX
Frequently Asked Questions
What product was recalled? ▼
Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.. Recalled by Brian P. Richardson. Units affected: 6000 packages.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 24, 2019. Severity: Critical. Recall number: D-1206-2019.
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