FDA recall D-1601-2014

Product

Xzone 1200, 750 mg, one capsule per blister pack, Distributed by: Xzone, Orlando, FL 32789

Reason for recall

Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZone 1200because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.

Distribution

Nationwide to retailers and distributors

Key facts

Status

Terminated

Initiation date

2014-03-28

Report date

2014-09-24

Termination date

2015-08-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Aston, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1601-2014