Hard Times For Men capsules…

Date

Jan. 31, 2018

Risk class

Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)

Status

Terminated

Filed by

www.blankterrmall.com

Product

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

Reason

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

Distribution pattern

Product was distributed in the United States.

Quantity

10 boxes

Codes and lots

All lots within expiry.

Recall started

Nov. 19, 2017

Recall number

D-0470-2018

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0470-2018. The agency record governs; check it and the company before acting.