Shogun-X 7000 capsule recalled over undeclared tadalafil

Recall date

March 29, 2021

Source

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

Official notice title

Nuri Trading LLC recalls Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC

Recall number

D-0685-2021

FDA classification

Class I

Brand / firm

Nuri Trading LLC

Sold / distributed

USA Nationwide

Why it was recalled

Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making them unapproved drugs for which the 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

Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC