FDA recall D-1614-2014

Eugene Oregon, Inc. · Class I · drug

Product

MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663

Reason for recall

Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.

Distribution

To retailers in MD, TX, FL, PA, IL, NJ, IN, LA, WA, ME, SC

Key facts

Status
Terminated
Initiation date
2014-05-05
Report date
2014-10-08
Termination date
2015-04-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Levittown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1614-2014