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