Brian P. Richardson recalls Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Ma
Recalled April 24, 2019 · FDA recall D-1206-2019 · Brian P. Richardson
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. · FDA Class I
Units
6000 packages
Sold at
Nationwide in the USA
Description
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
Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.
Manufacturer(s)
Brian P. Richardson
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →