Drug product
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
D-930-2013
Product summary
- Event
- Event 65130
- Status
- Terminated
- Classification
- Class I
- Quantity
- 145,632 capsules
- Official record key
drug-enforcement:D-930-2013
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: SKUs 626570613855, 626570619055, 626570617860, 626570617563
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