FDA-Drug2019-04-24Class I
Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.
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.
Sold states
Nationwide in the USA
Affected count
6000 packages
Manufactured in
3410 Delafield Ln, N/A, Dallas, TX, United States
Products
Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1206-2019Don't want to check this manually?
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