A company is voluntarily recalling its supplements after the U.S. Food and Drug Administration (FDA) found the products tainted with undeclared sildenafil (Viagra) and tadalafil (Cialis).
The company called NS NY Distributor Inc. issued the recall, which includes all lots of “Premium Orgazen 7000” and “Ginseng Power 5000 capsules,” according to the FDA.
The agency found the products contained with undeclared sildenafil and/or tadalafil – the prescription drugs that belong to the class of therapeutic agents called phosphodiesterase-5 (PDE-5) inhibitors.
PDE-5 inhibitors are recommended for the treatment of erectile dysfunction (ED) in men who are otherwise healthy. The drugs are not for men who have ED but also have cardiovascular risk. Besides, sildenafil and tadalafil are not advised to men who already take nitrates for angina (chest pain) or alpha-blockers for high blood pressure.
The FDA said earlier this month, “The presence of sildenafil and/or tadalafil in Premium OrgaZen 7000 and Ginseng Power 5000 makes them unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall.”
The U.S. drug regulatory body warned that people with underlying medical issues who take these supplements may experience serious health risks, such as severe hypotension (low blood pressure), which could be life-threatening.
Premium OrgaZen 7000 and Ginseng Power 5000 are sold as dietary supplements for male sexual enhancement. The package contains a single capsule blister foil sheet.
The tainted products were distributed across the United States through the internet by seller account Beauty.Kor. and fulfilled by Amazon, according to WHDH TV News. Consumers who have taken the supplements are being urged to contact their physician if they have experienced any side effects.