Product: MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA  90621, UPC 6 10079 52468 2.
Reason for recall: Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine.  Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug.  Dapoxetine is an active ingredient not approved
Recall initiated: 20131118
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated