FDA recall D-0772-2016

Product

Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA, UPC 700729253748

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-09-25

Report date

2016-03-16

Termination date

2022-05-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0772-2016