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Recall Observatory FDA recall evidence

Drug product

Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS

D-266-2013

March 10, 2012

Class I

Product summary

Firm
The Menz Club, LLC
Event
Event 63684
Status
Ongoing
Classification
Class I
Quantity
50,000 capsules
Official record key
drug-enforcement:D-266-2013

Official wording

Reason: 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

Code information: None

Distribution pattern: Utah

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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