More sex enhancement supplements are recalled by the FDA because of unlisted ingredients. At the beginning of the month the U.S. Food and Drug Administration sent an alert that New Jersey’s QMART recalled all lots of its Imperial Gold 2000, PremierZEN Extreme 3000, Burro en Primavera 60000 and Imperial Platinum 2000 products.
The FDA’s analysis found that QMART’s supplements were tainted with undeclared sildenafil and/or tadalafil. These are ingredients known as phosphodiesterase, or PDE-5 inhibitors for short, and are found in FDA-approved products for the treatment of male erectile dysfunction.
The problem is that while those ingredients are approved in products like Viagra and Cialis, those drugs have been tested and approved by the FDA. They also carry warnings for those who might be harmed by the inhibitors. The FDA isn’t opining on whether the QMART supplements perform as advertised — or don’t — but that the undeclared presence of sildenafil or tadalafil “renders them unapproved drugs for which the safety and efficacy have not been established.”
Consumers with underlying medical issues could experience serious health risks, the FDA said.
“For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates,” the FDA said.
QMART had not received any reports of adverse events when it issued its notice.
The tainted products are marketed as dietary supplements for male sexual performance enhancement and are packaged in cardboard blisters. All lots of Imperial Gold 2000 and Imperial Platinum 2000, PremierZEN Extreme 3000 and Burro en Primavera 60000 were distributed nationally through internet sales and also fulfilled by Amazon.
If you bought these supplements stop using and discard them, the FDA suggests.
This is at least the third FDA-inspired recall of male sexual enhancement supplements since December 2019. In January, a now dissolved company, Happy Together, issued a recall for the same reason: Its male sexual enhancement drugs, Rhino 5k, had sildenafil and tadalafil. The HawkScanner product compliance database is hooked up directly to the official FDA compliance list and with our featured live monitoring, HawkScanner alerts you when an ingredient gets flagged allowing you to act fast.
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