PrimeZen Black 6000

The FDA is advising consumers not to purchase or use PrimeZen Black 6000 because FDA laboratory analysis confirmed that PrimeZen Black 6000 contains sildenafil and tadalafil, the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction. FDA approvals of Viagra and Cialis are restricted to use under the supervision of a licensed healthcare professional. These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

For more information about this alert, click on the red button "Read Alert" below.

BACKGROUND: PrimeZen Black 6000 is a product promoted and sold for sexual enhancement on various websites, including https://voltcandy.com/, and possibly in some retail stores.

RECOMMENDATIONS:

• Consumers should exercise caution before purchasing any product promoted for sexual enhancement. FDA's Health Fraud Product Database includes only a small fraction of the potentially dangerous products marketed to consumers online and in stores.

Consumers and health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download the form or call 1-800-332-1088 to request a reporting form, then complete and return it to the address on the form, or submit it by fax to 1-800-FDA-0178.

This news report was shared by the FDA MedWatch and updated by Anita Johnson-Brown.

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