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Copyright © 2017 Natural Medicines (www.naturalmedicines.com)
September 2013

FDA: Hardmenstore.com Recalls Products Due To Undeclared Ingredient

Upon request of the U.S. Food and Drug Administration (FDA), Hardmenstore.com has issued a voluntary recall of 1,000 lots of their 72HP, Evil Root, and Pro Power Max products.

According to FDA representatives, these three products reportedly contain the undeclared component sildenafil, which is the active ingredient in an FDA-approved erectile dysfunction drug. Sildenafil is not listed on the product labels of 72HP, Evil Root, or Pro Power Max.

Sildenafil may interact with nitrates found in some prescription drugs, including nitroglycerin. Consumers who have diabetes, high blood pressure, high cholesterol levels, or heart disease often take nitrates. Sildenafil may lower blood pressure dangerously and may also cause side effects such as headaches and flushing.

The 72HP, Evil Root, and Pro Power Max products are marketed as dietary and sexual supplements. The 72HP and Pro Power Max products are both packaged in single-dose blister packs, while Evil Root is sold in a box containing a bottle with six pills. The 72HP product has yellow packaging with a black horse symbol; Evil Root is packaged in orange with blue Chinese characters; and Pro Power Max is sold in a black and red package with a flame design.

Hardmenstore.com is recalling all lots of 72HP, Evil Root, and Pro Power Max. The company is notifying both distributors and consumers by email, as well as an online notice on their website homepage. Hardmenstore.com urges any consumers or retails who have these supplements to stop using them immediately and to contact a healthcare professional if they experience any related side effects.

Questions may be directed to Howard Andrew via email at info@hardmenstore.com between Monday and Friday, 11am to 5pm Eastern time.

The FDA encourages consumers to report any side effects or quality problems associated with the use of these products to its MedWatch Adverse Event Reporting program through the internet, regular mail, or fax.

References

  1. Natural Standard: The Authority on Integrative Medicine. 
  2. US Food and Drug Administration. www.fda.gov

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