FDA Recall D-1657-2012
The Menz Club, LLC · Ridgeland, MS
Class I — life-threatening Terminated 1291 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-1657-2012- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2012-05-25
- Classified by FDA Center
- 2012-08-20
- FDA published
- 2012-08-29
- Terminated
- 2015-12-07
- Recalling firm
- The Menz Club, LLC
- Firm location
- Ridgeland, MS