March 31, 2014
Nova Products, Inc. Recalls Dietary Supplements with Undeclared Active Pharmaceutical Ingredients
The Missouri Department of Health and Senior Services received information regarding a recall of 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. The products contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
The products are 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.
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.
The full recall including a list of products can be found at www.fda.gov/Safety/Recalls/ucm391045.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.