[12-28-2015] The Food and Drug Administration (FDA) is advising consumers not to purchase or use OrgaZen 3500, a product promoted and sold for sexual enhancement on various websites and in some retail stores.
FDA laboratory analysis confirmed that OrgaZen 3500 contains tadalafil. Tadalafil, the active ingredient in the FDA-approved prescription drug Cialis, is used to treat erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
- Complete and submit the report online at MedWatch Online Voluntary Reporting Form, or;
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
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