Tuesday, April 01, 2014

Nova Products: Recall of African Black Ant, Black Ant, XZen Gold, ZXen Platinum, XZen 1200, and XZone Gold

Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling the following products: African Black Ant (Lot# 2006-000926), Black Ant (Lot# 2006-3627878), XZen Gold (Lot# 130310GL), ZXen Platinum (Lot# 130520PL), XZen 1200 (Lot# 13051012), XZone Gold (Lot# 131110GL), and XZone 1200 (Lot# 13071012) at the retail level. Lot numbers are identified on the back or side of each product. FDA laboratory analysis on these products has determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.

These undeclared active ingredients pose a threat to consumers because they can interact with nitrates found in some prescription drugs (such as nitroglycerin), resulting in decreased blood pressure. 

Prescription drugs containing nitrates are frequently prescribed for individuals with diabetes, high blood pressure, high cholesterol, or heart disease. Additionally, these products may cause side effects such as headaches and flushing.

These products are marketed as dietary supplements for sexual enhancement and packaged in blister packs, envelopes, bottles, and/or boxes distributed to consumers nationwide at retail stores. Nova Products, Inc. has discontinued distribution and sales of these products.
Nova Products, Inc. is notifying its distributors by mail of this voluntary recall. Consumers that possess these products should stop using them immediately and can return the products to Nova Products, Inc., 5 Mount Pleasant Road, Aston, Pennsylvania.

 http://www.fda.gov/Safety/Recalls/ucm391045.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery