FDA Recall D-1364-2014

Vitality Research Labs LLC · Las Vegas, NV

Class I — life-threatening Terminated 205 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

vitaliKOR Ready When You Are, Fast Acting Formula Dietary Supplement capsules, 40 count bottle, Distributed by Vitality Research Labs, LLC, Las Vegas, NV 89148.

Lot / code: LOT K58Q Exp 01/16 LOT F50Q Exp 07/16

Quantity: 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

Recall record

Recall number: D-1364-2014
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide
Recall initiated: 2013-11-19
Classified by FDA Center: 2014-06-11
FDA published: 2014-06-18
Terminated: 2014-06-12
Recalling firm: Vitality Research Labs LLC
Firm location: Las Vegas, NV

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