TOPIC: VitalityXtra and PeakMax Capsules by VitalityVita: Recall - Due to the Presence of Undeclared Sildenafil and Diclofenac
AUDIENCE: Consumer, Health Care Professional, Pharmacy, Cardiology, Gastroenterology
ISSUE: VitalityVita.com is recalling lot 230811 of VitalityXtra Capsules and PeakMax Capsules packaged in 10-count blisters because it was found to be tainted with sildenafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. PeakMax capsules were found to be tainted with sildenafil and diclofenac, an FDA approved drug known as a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation. Products containing sildenafil and diclofenac cannot be marketed as dietary supplements. VitalityVita and PeakMax capsules are unapproved new drugs for which safety and efficacy have not been established and, therefore, subject to recall.
Consumption of products with undeclared sildenafil 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.
Use of products with undeclared diclofenac may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.
The products were distributed via the internet at VitalityVita.com nationwide in the USA.
To date, VitalityVita 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: VitalityXtra and PeakMax are marketed as dietary supplements for male performance and energy.
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 that have VitalityXtra or PeakMax capsules lot number 230811 should stop using the product.
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VitalityVita is notifying its distributors and customers and is arranging for return of all recalled products. Please send all returns to 2108 N ST #7929 Sacramento, CA 95816.
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Consumers with questions regarding this recall can contact VitalityVita via e-mail at vitalityvitacorp@gmail.com.
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