FDA recall D-266-2013

Product

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

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

Distribution

Utah

Key facts

Status

Ongoing

Initiation date

2012-03-10

Report date

2013-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ridgeland, MS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-266-2013