Hard Times For Men capsules recalled over undeclared active

Recall date

November 19, 2017

Source

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

Official notice title

www.blankterrmall.com recalls Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one capsule per pack, www.hardTimes…

Recall number

D-0470-2018

FDA classification

Class I

Brand / firm

www.blankterrmall.com

Sold / distributed

Product was distributed in the United States.

Why it was recalled

Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.

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

Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one capsule per pack, www.hardTimesPill.com, Distributed by: Natural Works LLC, USA