FDA recall D-0673-2016

Product

Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA

Reason for recall

Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-09-30

Report date

2016-02-24

Termination date

2017-06-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Santa Clarita, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0673-2016