FDA recall D-0470-2018

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 for recall

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

Distribution

Product was distributed in the United States.

Key facts

Status

Terminated

Initiation date

2017-11-19

Report date

2018-01-31

Termination date

2018-12-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Olean, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0470-2018