FDA-Drug2014-09-24Class I

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

Nova Products, Inc.
Hazard

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.

Sold states
Nationwide to retailers and distributors
Affected count
Unknown
Manufactured in
5 Mount Pleasant Rd, N/A, Aston, PA, United States
Products
Xzone 1200, 750 mg, one capsule per blister pack, Distributed by: Xzone, Orlando, FL 32789

Official notice

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

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