FDA Recall D-266-2013

The Menz Club, LLC · Ridgeland, MS

Class I — life-threatening Ongoing 5178 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

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

Lot / code: None

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 record

Recall number: D-266-2013
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Utah
Recall initiated: 2012-03-10
Classified by FDA Center: 2013-04-18
FDA published: 2013-04-24
Recalling firm: The Menz Club, LLC
Firm location: Ridgeland, MS

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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