Why it was recalled
Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug
Product description
SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 and 12 capsule bottles, Manufactured For: BeaMonstar Products, Queen Creek, AZ
Lot numbers, UPCs & expiration codes
All lots of product distributed and sold from January 2012 to May 7, 2013 SKUs: 626570609490, 827912089028, 626570617877, 626570615316, 626570623588
Where it was sold
US states nationwide and international.
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-929-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 1, 2013
- FDA report date
- Sep 11, 2013
- Quantity
- 673,851 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Beamonstar Products
Original FDA data
Every field from FDA enforcement report D-929-2013, exactly as published.
Show all FDA fields
- City
- Queen Creek
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 65130
- Address
- 530 E Hunt Hwy
- Address (line 2)
- Ste 103
- Code information
- All lots of product distributed and sold from January 2012 to May 7, 2013 SKUs: 626570609490, 827912089028, 626570617877, 626570615316, 626570623588
- Postal code
- 85243
- Report date
- Sep 11, 2013
- Product type
- Drugs
- Recall number
- D-929-2013
- Classification
- Class I
- Recalling firm
- Beamonstar Products
- Product quantity
- 673,851 capsules
- Termination date
- Apr 21, 2014
- Reason for recall
- Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 and 12 capsule bottles, Manufactured For: BeaMonstar Products, Queen Creek, AZ
- Distribution pattern
- US states nationwide and international.
- Recall initiation date
- May 1, 2013
- Initial firm notification
- Center classification date
- Sep 5, 2013