Kopi Jantan Tradisional Natural Herbs Coffee recalled over undeclared sildenafil

Recall date

April 5, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Brian P. Richardson recalls Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, M…

Recall number

D-1206-2019

FDA classification

Class I

Brand / firm

Brian P. Richardson

Sold / distributed

Nationwide in the USA

Why it was 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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.