FDA recall D-1657-2012

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-05-25

Report date

2012-08-29

Termination date

2015-12-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ridgeland, MS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1657-2012