D-1598-2014 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 24, 2014
- Initiation Date
- March 28, 2014
- Termination Date
- August 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Unknown
Product Description
XZEN GOLD,750 mg, six capsules per bottle, 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 GOLD 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 Pattern
Nationwide to retailers and distributors
Code Information
Lot# 130310GL