TOPIC: Vitality Capsules by One Source Nutrition: Recall - Due to Presence of Undeclared Sildenafil and Tadalafil
AUDIENCE: Consumer, Health Care Professional, Pharmacy
ISSUE: One Source Nutrition is recalling all lots of Vitality capsules because FDA analysis has found the product to be tainted with sildenafil and tadalafil, which are ingredients in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. Products containing sildenafil and tadalafil cannot be marketed as dietary supplements. Vitality capsules are an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.
Risk Statement: Consumption of products with undeclared sildenafil and tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk.
To date, One Source Nutrition has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The tainted Vitality capsules are marketed as a dietary supplement used as a male enhancement product.
RECOMMENDATIONS:
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Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.
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Consumers should return all purchased product to place of purchase.
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Retailers that have Vitality capsules which is being recalled should return to place of purchase/discard/contact their doctor, etc.
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Consumers with questions regarding this recall can contact One Source Nutrition by 501-778-3311 or onesourcelr@gmail.com.
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