FUEL UP HIGH OCTANE recalled over undeclared hydroxythiohomosildenafil

Recall date

December 11, 2015

Source

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

Official notice title

Reesna, Inc recalls FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM

Recall number

D-0960-2016

FDA classification

Class I

Brand / firm

Reesna, Inc

Sold / distributed

Nationwide and United Kingdom

Why it was recalled

Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.

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

FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM