FDAFDA · Food and drugs·Recall number D-1601-2014
Xzone 1200, 750 mg, one capsule per blister pack, Distributed by: Xzone, Orlando, FL 32789
Published September 24, 2014 · Recall initiated: March 28, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Nova Products, Inc.
- Distributor
- Nationwide to retailers and distributors
- Lot
- Lot# 13071012
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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