(WHDH) — A Northeast-based company is voluntarily recalling a pair of supplements that contain undeclared ingredients commonly found in male-enhancement products such as Viagra and Cialis, according to the U.S. Food and Drug Administration.
The recall issued by NS NY Distributor Inc. includes all lots within expiry of Premium Orgazen 7000 and Ginseng Power 5000 capsules, the FDA announced earlier this month.
Studies revealed the products to contain undeclared sildenafil and/or tadalafil, which are also known as phosphodiesterase inhibitors found in FDA approved products for the treatment of male erectile dysfunction, according to the announcement.
“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 FDA said.
The FDA warned that consumers with underlying medical issues who take the supplements may experience serious health risks, including lowering blood pressure to dangerous levels that may be life-threatening.
These tainted products are marketed as a dietary supplements for male sexual enhancement and are packaged in a single capsule blister foil sheet and sold in lots of 3 capsules, 5 capsules and 10 capsules.
The affected lot numbers of Premium OrgaZen 7000, UPC 0 40232 18144 3, and Ginseng Power 5000, UPC 0 40232 18144 3 include all lots. Premium OrgaZen 7000 and Ginseng Power 5000 were distributed nationwide in the USA via the internet by seller account Beauty.Kor. and fulfilled by Amazon.
Consumers are being urged to contact their physician or healthcare provider if they have experienced any problems that may be related to taking the recalled products.
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