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FDA Recalls ACTRA-Sx 500 for Undeclared Viagra

FDA Recalls ACTRA-Sx 500 for Undeclared Viagra

September 18, 2012 — Body Basics, Inc., and the U.S. Food and Drug Administration (FDA) have announced a voluntary recall of Actra-Sx 500, a dietary supplement sold to treat erectile dysfunction. An independent chemical analysis of the supplement revealed an undeclared ingredient, Sildenafil citrate, which is the active ingredient in Viagra. The FDA is warning that people who take Actra-Sx 500 and other medications may suffer life-threatening low blood pressure (hypotension).

Each package of Actra-Sx 500 contains five pills, colored purple and gold. The boxes are marked with Lot 008-A and have an expiration date of December 2013. Body Basics voluntarily stopped selling Actra-Sx 500 in November 2011, but some people may still have this product in their possession.

The FDA warns:

“Use of this product may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.”

Erectile dysfunction (inability to gain or maintain an erection during sexual activity) commonly affects men with metabolic and cardiovascular disorders — including diabetes, high cholesterol, high blood pressure, heart disease, and more. Medications to treat these diseases often contain nitrates, which could interact with the undeclared ingredients in Actra-Sx 500. The combination of Actra-Sx 500 and a medication containing nitrates could cause hypotension (low blood pressure).

Symptoms of low blood pressure may include:

  • Loss of consciousness
  • Dizziness, light-headedness
  • Having trouble concentration
  • Vision blurriness
  • Nausea, vomiting
  • Shallow breathing
  • Fatigue
  • Depression
  • Severe thirst

Do I have an Actra-Sx 500 Lawsuit?

The Schmidt Firm, PLLC is currently accepting Actra-Sx 500 induced injury cases in all 50 states. If you or somebody you know has been injured by Actra-Sx 500, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Dietary Supplement Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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