FDA recall D-1599-2014

Product

XZEN PLATINUM, 750 mg, 1 capsule per blister pack, Distributed by: XZEN, City of Los Angeles, CA 90012

Reason for recall

Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN PLATINUM because FDA laboratory analysis determined 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-1599-2014