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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Event Detail

Event ID 61957
Product Type Drugs
Status Ongoing
Recalling Firm The Menz Club, LLC
City Ridgeland
State MS
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-25
Initial Firm Notification of
Consignee or Public
Press Release
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Lot #s: a) 101108, 101009, 101010, 101011; b) 101108, 101109, 101110; c) 301000, 301001 Class I 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. 585,000 Capsules D-1657-2012