The FDA has issued a safety alert to consumers involving several dietary supplements including Rhino 7, Papa Zen, Fifty Shades, and Grande X. The safety alert warns consumers that the products may include undeclared active prescription drug ingredients.
The products are labeled as a dietary supplement and each is packaged as a blister pack capsule. Product names and lot numbers are available in the FDA’s safety alert.
Voluntary Recall of Dietary Supplements
Gadget Island, Inc. is voluntarily recalling the dietary supplements at the consumer level. The products have been found to contain undeclared active pharmaceutical ingredients – sildenafil, desmethyl carbodenafil, and tadalafil.
Undeclared Active Ingredients May Pose Danger to Consumers
Use of products with undeclared active ingredients sildenafil, tadalafil and desmethyl carbodenafil may pose a threat to consumers. The active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin). That could cause a significant drop in blood pressure that may be life threatening.
Men Who Use Nitrates for Cardiac Conditions Are Most At Risk
Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are the most at risk from these products.
FDA Recommendations
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking these products.