D-266-2013 Class I Ongoing
FDA drug recall D-266-2013 was initiated by The Menz Club, LLC on March 10, 2012 and is designated Class I. 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 … The recall status is ongoing. Affected quantity: 50,000 capsules.
Recall Details
- Product Type
- Drugs
- Report Date
- April 24, 2013
- Initiation Date
- March 10, 2012
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50,000 capsules
Product Description
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
Distribution Pattern
Utah
Code Information
None