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Nova Products, Inc. Dietary Supplements: Recall - Undeclared Drug Ingredients

Including African Black Ant, Black Ant, XZen Gold, ZXen Platinum, XZen 1200, XZone Gold, and XZone 1200

[Posted 03/31/2014]

AUDIENCE: Consumer

ISSUE: Nova Products, Inc. issued a voluntary recall of 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. 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.

BACKGROUND: 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. Lot numbers are identified on the back or side of each product.

RECOMMENDATION: Consumers that possess these products should stop using them immediately and return the products to Nova Products, Inc., 5 Mount Pleasant Road, Aston, Pennsylvania. Consumers with questions regarding this recall can contact Nova Products, Inc. by telephone at 610-459-7709 between 9:00 a.m. and 5:00 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.

[03/31/2014 - Press Release - Nova Products, Inc]