Product: Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS
Reason for recall: Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved product used for erectile dysfunction, making it an unapproved new drug
Recall initiated: 20120310
Status: Ongoing
Classification: Class I
Recall type: Voluntary: Firm initiated