Product: Rhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack, Distributed by P&A Enterprise, Buena Park, CA  90621, English UPC 6 10708 10730 9, Spanish UPC 6 10708 10729 3.
Reason for recall: Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5 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 by
Recall initiated: 20131118
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated