Why it was recalled
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Product description
Virilis Pro, 450mg/capsule, Packaged in a 1 and 2 capsule blister packs and 10 capsule bottles, Manufactured for Haute Health Williamstown, NJ 08094 website: http://www.virilispro.com
Lot numbers, UPCs & expiration codes
All lot codes and expiration dates.
Where it was sold
Nationwide and internationally via internet sales.
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-1237-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 27, 2013
- FDA report date
- Apr 23, 2014
- Quantity
- 82,944 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Haute Health, LLC
Original FDA data
Every field from FDA enforcement report D-1237-2014, exactly as published.
Show all FDA fields
- City
- Williamstown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 66406
- Address
- 614 Atlanta Ct
- Code information
- All lot codes and expiration dates.
- Postal code
- 08094-3549
- Report date
- Apr 23, 2014
- Product type
- Drugs
- Recall number
- D-1237-2014
- Classification
- Class I
- Recalling firm
- Haute Health, LLC
- Product quantity
- 82,944 capsules
- Termination date
- Jan 29, 2015
- Reason for recall
- Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Virilis Pro, 450mg/capsule, Packaged in a 1 and 2 capsule blister packs and 10 capsule bottles, Manufactured for Haute Health Williamstown, NJ 08094 website: http://www.virilispro.com
- Distribution pattern
- Nationwide and internationally via internet sales.
- Recall initiation date
- Sep 27, 2013
- Initial firm notification
- Press Release
- Center classification date
- Apr 15, 2014