Drug product
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
D-929-2013
Product summary
- Event
- Event 65130
- Status
- Terminated
- Classification
- Class I
- Quantity
- 673,851 capsules
- Official record key
drug-enforcement:D-929-2013
Official wording
Reason: 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
Code information: All lots of product distributed and sold from January 2012 to May 7, 2013 SKUs: 626570609490, 827912089028, 626570617877, 626570615316, 626570623588
Distribution pattern: US states nationwide and international.
Derived failure modes
-
Unknown
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