FDA recall D-1364-2014

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.

Reason for recall

Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-11-19

Report date

2014-06-18

Termination date

2014-06-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Las Vegas, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1364-2014