FDA recall D-327-2013

Product

Mojo Nights, 1 capsule, UPC 7 18122 11983 7, Distributed By: Mojo Health Lauderhill, FL 33351

Reason for recall

Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-08-23

Report date

2013-05-22

Termination date

2013-07-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kennesaw, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-327-2013