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A distributor has recalled a male enhancement supplement nationwide after regulators discovered it contained the same substances as the erectile dysfunction drug Viagra.
In a notice issued last week, the Food and Drug Administration (FDA) warned that Premium Orgazen 7000 and Ginseng Power 5000 capsules may contain undeclared sildenafil and/or tadalafil, substances that can be life-threatening to those who take certain prescription medications. NS NY Distributor Inc has voluntarily recalled all lots of these supplements, which are advertised for male sexual enhancement.
“Consumers with underlying medical issues who take Premium OrgaZen 7000 capsules and Ginseng Power 5000 with undeclared sildenafil and/or tadalafil may experience serious health risks,” warns the FDA’s recall notice. “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 notice goes on to say that the distributor has not yet received any reports of injuries or adverse events related to the recall of its male enhancement supplement, but the agency urges consumers to stop using the products and to destroy them.
The recalled supplement was sold across the country in single capsule blister foil sheets in lots of 3, 5, and ten capsules. The products, Premium OrgaZen 7000 and Ginseng Power 5000, were sold online and fulfilled by Amazon.com.
Premium OrgaZen 7000 and Ginseng Power 5000 were recalled because they contain phosphodiesterase (PDE-5) inhibitors found in FDA-approved products for the treatment of male erectile dysfunction, including Viagra. The presence of these substances made the male enhancement supplements unapproved drugs – a growing trend warns the agency in a separate publication about tainted sexual enhancement products.
“Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients,” says the FDA.
Indeed, earlier this month multiple male sexual enhancement products sold by a Korean company were recalled over undeclared tadalafil, sildenafil, and/or vardenafil — the active ingredients used to treat erectile dysfunction in prescription pills like Viagra and Cialis.
Have you purchased recalled supplements online? What do you think of this latest recall? Tell us in the comment section below!
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