FDA recall D-1248-2014

Fossil Fuel Products, LLC · Class I · drug

Product

RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309

Reason for recall

Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil.

Distribution

Nationwide.

Key facts

Status
Terminated
Initiation date
2013-11-18
Report date
2014-04-30
Termination date
2015-05-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dallas, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1248-2014