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Class I: serious health riskTerminated

Vitality Research Labs vitaliKOR Ready When You Are Recall

vitaliKOR Ready When You Are, Fast Acting Formula Dietary Supplement capsules, 40 count…

Vitality Research Labs LLC · Las Vegas, NV

Risk level
Class I
Reported by FDA
Jun 18, 2014
Recall ID
D-1364-2014
Check your lot numberHow we source this data

Summary

Vitality Research Labs recalled vitaliKOR Ready When You Are starting Nov 19, 2013. The FDA classified it as Class I (serious health risk) and published enforcement report D-1364-2014 on Jun 18, 2014. Reason: Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules. Status: Terminated.

Why it was recalled

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

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.

Lot numbers, UPCs & expiration codes

LOT K58Q Exp 01/16 LOT F50Q Exp 07/16

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1364-2014
Classification
Class I
Status
Terminated
Recall initiated
Nov 19, 2013
FDA report date
Jun 18, 2014
Quantity
11,523 bottles of lot K58Q; 54,255 bottles of lot F50Q
Recall type
Voluntary: Firm initiated
Recalling firm
Vitality Research Labs LLC

Original FDA data

Every field from FDA enforcement report D-1364-2014, exactly as published.

Show all FDA fields
City
Las Vegas
State
NV
Status
Terminated
Country
United States
Event ID
66839
Address
8840 W Russell Rd #245
Code information
LOT K58Q Exp 01/16 LOT F50Q Exp 07/16
Postal code
89148
Report date
Jun 18, 2014
Product type
Drugs
Recall number
D-1364-2014
Classification
Class I
Recalling firm
Vitality Research Labs LLC
Product quantity
11,523 bottles of lot K58Q; 54,255 bottles of lot F50Q
Termination date
Jun 12, 2014
Reason for recall
Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Nationwide
Recall initiation date
Nov 19, 2013
Initial firm notification
Press Release
Center classification date
Jun 11, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1364-2014, published Jun 18, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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