March 2012 FDA Recall Drug by The Menz Club, Llc
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

This Class I drug recall was voluntarily initiated by The Menz Club, Llc on March 10, 2012 for the product Drug. The FDA reported the reason for recall as 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. The product was distributed in Utah and the recall is currently ongoing.

Recall Number: D-266-2013

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
Initiated
03-10-2012
Reported
04-24-2013
Quantity
50,000 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63684
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Menz Club, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Utah
Product Description About Product Description
Full technical description of the product.
Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS

Batch or Lot Expiration Information

Lot# None