FDAApril 5, 2019drug
Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.
Official recall recorded by the U.S. Food & Drug Administration.
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
FDA enforcement status: Terminated
Brands named
brian p richardsonbrian
UPCs
9557205060083
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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