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
Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 & 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: SKUs 626570613855, 626570619055, 626570617860, 626570617563
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-930-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 1, 2013
- FDA report date
- Sep 11, 2013
- Quantity
- 145,632 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Beamonstar Products
Original FDA data
Every field from FDA enforcement report D-930-2013, 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: SKUs 626570613855, 626570619055, 626570617860, 626570617563
- Postal code
- 85243
- Report date
- Sep 11, 2013
- Product type
- Drugs
- Recall number
- D-930-2013
- Classification
- Class I
- Recalling firm
- Beamonstar Products
- Product quantity
- 145,632 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
- Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 & 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