Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one capsule p...
FDA Recall #D-0470-2018 — Class I — November 19, 2017
Product Description
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.
Recalling Firm
www.blankterrmall.com — Olean, NY
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
10 boxes
Distribution
Product was distributed in the United States.
Code Information
All lots within expiry.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated