FDA Recall D-1598-2014
Nova Products, Inc. · Aston, PA
Class I — life-threatening Terminated 496 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-1598-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide to retailers and distributors
- Recall initiated
- 2014-03-28
- Classified by FDA Center
- 2014-09-18
- FDA published
- 2014-09-24
- Terminated
- 2015-08-06
- Recalling firm
- Nova Products, Inc.
- Firm location
- Aston, PA