WASHINGTON, DC – The US Food and Drug Administration has reported that NS NY Distributor Inc. has initiated a nationwide recall of its Premium Orgazen 7000 and Ginseng Power 5000 capsules due to undisclosed sildenafil and/or tadalafil. Sildenafil and tadalafil are phosphodiesterase inhibitors used in FDA-approved male erectile dysfunction products such as Viagra and Cialis. The FDA stated that consumers who have underlying medical issues and consume sildenafil and tadalafil could experience dangerous health effects, including a life-threatening drop in blood pressure.
This announcement from NS NY Distributor Inc. states that all lots of the company’s Ginseng Power 5000 capsules and Premium Orgazen 7000 are affected by this recall. The FDA also stated that the presence of tadalafil and/or sildenafil Ginseng Power 5000 or Premium OrgaZen 7000 makes the supplements “unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall.”
The affected supplements are described as male sexual enhancement dietary supplements and are packaged in a capsule blister foil sheet. The products are sold in lots of three capsules, five capsules, and ten capsules. The recalled affects all product lot numbers and the product name and UPC codes are:
- Premium OrgaZen 7000, UPC 0 40232 18144 3, and
- Ginseng Power 5000, UPC 0 40232 18144 3
Ginseng Power 5000 and Premium OrgaZen 7000 were distributed throughout the United States via the internet by seller account “Beauty.Kor.” and then fulfilled by Amazon.
Customers are being urged to speak with their physician or medical provider if experiencing any health problems that may be related to these recalled supplements.
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