Status
Terminated
Drug Enforcement D-929-2013
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
Classification
Class I
Report Date
September 11, 2013
Termination Date
April 21, 2014
Product Information
- 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
- Product quantity
- 673,851 capsules
- 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
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- US states nationwide and international.
Location & Firm
- Recalling firm
- Beamonstar Products
- Address
-
530 E Hunt Hwy, Ste 103
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-929-2013
- Event ID
- 65130
- Recall initiation date
- May 1, 2013
- Center classification date
- September 5, 2013
- Code info
- All lots of product distributed and sold from January 2012 to May 7, 2013 SKUs: 626570609490, 827912089028, 626570617877, 626570615316, 626570623588
- More code info
- —