FDA recall D-021-2014

Product

J.R. Jack Rabbit All Natural Herbal Supplement, One tablet can last 24-72 hours, 4-count tablets per blister pack, Order at: www.jackrabbitfourpack.com, Jack Rabbit Inc., 4355 Dow Road, Melbourne, FL 32934

Reason for recall

Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that J.R. Jack Rabbit Male Enhancement product was found to contain two undeclared active pharmaceutical ingredients: sildenafil and tadalafil.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-08-12

Report date

2013-12-04

Termination date

2020-10-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Melbourne, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-021-2014