vitaliKOR Ready When You Are, Fast Acting Formula Dietary Supplement capsules, 40 count bottle, D...
FDA Recall #D-1364-2014 — Class I — November 19, 2013
Product Description
vitaliKOR Ready When You Are, Fast Acting Formula Dietary Supplement capsules, 40 count bottle, Distributed by Vitality Research Labs, LLC, Las Vegas, NV 89148.
Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules
Recalling Firm
Vitality Research Labs LLC — Las Vegas, NV
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
11,523 bottles of lot K58Q; 54,255 bottles of lot F50Q
Distribution
Nationwide
Code Information
LOT K58Q Exp 01/16 LOT F50Q Exp 07/16
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated