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

Recall Number: D-1599-2014

Firm: Nova Products, Inc.

Classification: Class I

Status: Terminated

Report Date: 20140924

Initiation Date: 20140328

Termination Date: 20150806

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.

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