MAN OF STEEL capsules recalled over undeclared sildenafil

Recall date

June 22, 2017

Source

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

Official notice title

Vitility recalls MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop Solutions, LLC, POB 231693, Sacramento, C…

Recall number

D-0032-2018

FDA classification

Class I

Brand / firm

Vitility

Sold / distributed

Nationwide in the USA

Why it was recalled

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of 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

MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop Solutions, LLC, POB 231693, Sacramento, California 95823; vitility@yahoo.com; www.manofsteelpills.com; UPC 1 0001001378 7.