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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Product Detail

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.
Recall Number D-1364-2014
Classification Class I
Code Info LOT K58Q Exp 01/16 LOT F50Q Exp 07/16
Product Distributed Qty 11,523 bottles of lot K58Q; 54,255 bottles of lot F50Q
Reason For Recall Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules

Event Detail

Event Id 66839
Product Type Drugs
Status Terminated
Recalling Firm Vitality Research Labs LLC
City Las Vegas
State NV
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-19
Initial Firm Notification of Consignee or Public Press Release
Distribution Pattern Nationwide