drugs Class I Updated 2014-09-24

Nova Products, Inc. recalls XZONE GOLD, 750 mg, one capsule blister pack, Distributed

Recalled Product

XZONE GOLD, 750 mg, one capsule blister pack, Distributed by: XZONE, Orlando, FL 32789

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: lot# 131110GL
View official government recall

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