Home / Recalls / Nova Products, Inc. / D-1602-2014

D-1602-2014 Class I Terminated

Recalled by Nova Products, Inc. — Aston, PA

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

XZONE GOLD, 750 mg, one capsule blister pack, Distributed by: XZONE, Orlando, FL 32789

Reason for Recall

Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZONE GOLD because FDA laboratory analysis determined that 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# 131110GL

Other recalls by Nova Products, Inc.

  • D-1599-2014 Class I — XZEN PLATINUM, 750 mg, 1 capsule per blister pack, Distributed by: XZEN, City of (March 28, 2014)
  • D-1596-2014 Class I — AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei (March 28, 2014)
  • D-1597-2014 Class I — Black Ant, 4600 mg, four capsules per box, , Manufacturer Timpo Bioengineering C (March 28, 2014)
  • D-1601-2014 Class I — Xzone 1200, 750 mg, one capsule per blister pack, Distributed by: Xzone, Orland (March 28, 2014)
  • D-1598-2014 Class I — XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los Ang (March 28, 2014)
  • D-1600-2014 Class I — Xzen 1200, 750 mg, six capsules per bottle, Distributed by: xzen, City of Los An (March 28, 2014)
  • D-1603-2014 Class I — MOJO RISEN ,670 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Sprin (March 28, 2014)