Product: eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Company, Buena Park, CA  90621, UPC 6 89076 49126 6.
Reason for recall: Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone 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 b
Recall initiated: 20131118
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated