Red Zone Xtreme 3000 Capsules recalled over undeclared tadalafil

Recall date

March 8, 2018

Source

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

Official notice title

Jimmy Weber recalls Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pack, UPC 8 91656 00200 9, Exp Date 12/31/20…

Recall number

D-0625-2018

FDA classification

Class I

Brand / firm

Jimmy Weber

Sold / distributed

Product was distributed online via eBay.

Why it was recalled

Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.

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

Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pack, UPC 8 91656 00200 9, Exp Date 12/31/2021