D-1364-2014 Class I Terminated
FDA drug recall D-1364-2014 was initiated by Vitality Research Labs LLC on November 19, 2013 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules The recall status is terminated (terminated June 12, 2014). Affected quantity: 11,523 bottles of lot K58Q; 54,255 bottles of lot F50Q.
Recall Details
- Product Type
- Drugs
- Report Date
- June 18, 2014
- Initiation Date
- November 19, 2013
- Termination Date
- June 12, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,523 bottles of lot K58Q; 54,255 bottles of lot F50Q
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
Distribution Pattern
Nationwide
Code Information
LOT K58Q Exp 01/16 LOT F50Q Exp 07/16