Home / Recalls / The Menz Club, LLC / D-1657-2012

D-1657-2012 Class I Terminated

Recalled by The Menz Club, LLC — Ridgeland, MS

Recall Details

Product Type: Drugs
Report Date: August 29, 2012
Initiation Date: May 25, 2012
Termination Date: December 7, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 585,000 Capsules

Product Description

V Maxx Rx, All Natural Male Enhancement, a) 1-count blister pack UPC Code 2802803561; b) 5-count blister pack UPC Code 0972859402; c) 10-count bottle UPC code 0913251017 bottles, Manufactured by The Menz Club, LLC, 103 W. Washington Street, Suite B5, Ridgeland, MS 39157, Phone: 601-866-6746

Reason for Recall

Marketed Without An Approved NDA/ANDA: Samples tested by FDA were found to contain sulfoaildenafil, an analogue of sildenafil, an FDA approved drug used in the treatment of male erectile dysfunction, making these products unapproved new drugs.

Distribution Pattern

Nationwide

Code Information

Lot #s: a) 101108, 101009, 101010, 101011; b) 101108, 101109, 101110; c) 301000, 301001