Drug 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.
D-1364-2014
Product summary
- Event
- Event 66839
- Status
- Terminated
- Classification
- Class I
- Quantity
- 11,523 bottles of lot K58Q; 54,255 bottles of lot F50Q
- Official record key
drug-enforcement:D-1364-2014
Official wording
Reason: Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules
Code information: LOT K58Q Exp 01/16 LOT F50Q Exp 07/16
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules