INDIANAPOLIS — A dietary supplement is being recalled because it is tainted with the active ingredient in the prescription drugs Viagra and Cialis.
The Food and Drug Administration (FDA) says the recall involves one lot of Volt Candy’s PrimeZen Black 6000. The recall was initiated after an FDA analysis found the product was tainted with sildenafil and tadalafil.
The recall comes as the FDA is warning companies that selling products that contain undisclosed or hidden prescription medication violates federal law. In early July, the FDA sent warning letters to four companies that sold honey products that contained undeclared active ingredients, including sildenafil and tadalafil.
Sildenafil and tadalafil are the active drug ingredients found in Viagra and Cialis, respectively. They are restricted to use under the supervision of licensed healthcare professionals. The FDA said these undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.
The product is marketed as a dietary supplement for male sexual enhancement and is packaged in a blister card with one capsule, UPC code: 728175521891. The affected PrimeZen Black 6000 includes the following lot number [NPINPB 1003] with an expiration date of 08/16/2025.
Because the product is listed as a dietary supplement, it is regulated by the FDA as food, not drugs. Under the law, the FDA does not have the authority to approve dietary supplements for safety and effectiveness or approve their labeling. It is the responsibility of the company to make sure its products meet safety standards and are not violating the law.
However, tadalafil and sildenafil products are excluded from the dietary supplement definition. Their presence makes the products unapproved drugs for which safety and efficacy have not been established.
Anyone with the recalled capsules should stop using them and return them. Anyone with questions can contact Volt Candy by e-mail firstname.lastname@example.org on weekdays between 9am-5pm PST.
Anyone who experiences an adverse event, also known as a side effect or bad reaction, should report it to their health care professional and FDA. The FDA says even a single adverse event report can help them identify a potentially dangerous product and possibly remove it from the market.
Adverse reactions or quality problems may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178