D-1600-2014 Class I Terminated
FDA drug recall D-1600-2014 was initiated by Nova Products, Inc. on March 28, 2014 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Xzen 1200 because FDA laboratory analysis determined they contain undeclared amounts of silde… The recall status is terminated (terminated August 6, 2015). Affected quantity: Unknown.
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 1200, 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 1200 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# 13051012