Status
Ongoing
Drug Enforcement D-266-2013
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
Classification
Class I
Report Date
April 24, 2013
Termination Date
—
Product Information
- Product description
- Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS
- Product quantity
- 50,000 capsules
- 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 initiation reason
- —
- Initial firm notification
- Distribution pattern
- Utah
Location & Firm
- Recalling firm
- The Menz Club, LLC
- Address
-
103 W. Washington Street, Suite B5
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-266-2013
- Event ID
- 63684
- Recall initiation date
- March 10, 2012
- Center classification date
- April 18, 2013
- Code info
- None
- More code info
- —