Night Bullet: Recall - Undeclared Drug Ingredient

ISSUE: Green Planet, Inc. notified the public of a recall of its dietary supplement product Night Bullet. Analytical tests conducted by the FDA found that the product contains trace amounts of Sulfohydroxyhomosildenafil and Aminotadalafil, which are analogues of sildenafil. Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED), making this product an unapproved drug.

The following product lot is being recalled: B43N032, UPC code 018505122233, Expiration Date 10/2015. These undeclared active ingredients pose a threat to consumers because sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates. ED is a common problem in men with these conditions and they may seek products to enhance sexual performance. Sildenafil may also cause side effects such as headaches and flushing.

Magic Power Coffee: Potentially Dangerous—Not Magical

Consumers should not use an instant coffee being sold online as a dietary supplement for sexual enhancement, warns the Food and Drug Administration (FDA).

The product, Magic Power Coffee, contains a potentially dangerous ingredient. The product is sold in a two-serving box as well as in a carton that contains six two-serving boxes.

FDA’s lab analysis determined that Magic Power Coffee contains a chemical similar to the active ingredient in the prescription drug Viagra to treat erectile dysfunction. The chemical may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure.

Although Magic Power Coffee is labeled as an “all natural dietary supplement,” it can cause serious harm. Sexual enhancement products that claim to work as well as prescription products are likely to expose consumers to unpredictable risks and the potential for injury or even death.

Public Notification: “Hard Ten Days” Contains Undeclared Drug Ingredient

[2-18-2012] The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Hard Ten Days,” a product for sexual enhancement sold on various websites.  FDA laboratory analysis confirmed that “Hard Ten Days” contains sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for Erectile Dysfunction (ED).  


Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.  Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

Consumers should stop using this product immediately and throw it away.  Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. (See label)

Public Notification: “Man King” Contains Undeclared Drug Ingredient

[2-18-2012] The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Man King,” a product for sexual enhancement sold on various websites.  


FDA laboratory analysis confirmed that “Man King” contains sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for Erectile Dysfunction (ED).  Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.  Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

Consumers should stop using this product immediately and throw it away.  Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. (See Label)

Public Notification: Rock Hard Extreme and Passion Coffee Contain Undeclared Drug Ingredient

[12/30/2010] The Food and Drug Administration (FDA) is advising consumers not to purchase or use Rock Hard Extreme and Passion Coffee, products promoted and sold as dietary supplements for sexual enhancement. 


These products are promoted and sold on various websites, such as www.drivetotalenergy.com,  and possibly in some retail stores.

FDA laboratory analysis confirmed that Rock Hard Extreme and Passion Coffee contain the undeclared ingredient sulfoaildenafil. Sulfoaildenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for Erectile Dysfunction (ED). 

Caution about Sexual Enhancement Products

FDA Consumer Corner

You can easily find them on the internet - products sold as "dietary supplements" to enhance sexual performance or treat erectile dysfunction. Many of these products are said to be "all natural" alternatives to prescription drugs. That might make you think they're harmless. But they may not be.


FDA has found that many of these supposedly "all natural" products actually contain ingredients that aren't on the label, and these ingredients could lead to serious and even fatal effects.


An FDA investigation of a number of these sexual enhancement supplements found that a third of them actually contained the same or similar ingredients to the class of prescription drugs that includes Viagra (sildenafil citrate), Cialis (tadalafil) and Levitra (vardenafil HCl.

Stiff Nights - product contains undeclared drug ingredient

Audience: Consumers, Pharmacists

[Posted 11/05/2009] FDA notified consumers that Stiff Nights, a product sold as a dietary supplement, contains sulfoaildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. 


Sulfoaildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. The product is distributed on Internet sites and at retail stores by Impulsaria LLC of Grand Rapids, Michigan. It is sold in bottles containing 6, 12, or 30 red capsules or in blister packs containing one or two capsules. 

The FDA advises consumers who have experienced any adverse events from sexual enhancement products to consult a health care professional. 


Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178].

[11/05/2009 - News Release - FDA]
[11/05/2009 - Hidden Risks of Erectile Dysfunction "Treatments" Sold Online - FDA Consumer Updates]

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189300.htm

Hidden Risks of Erectile Dysfunction "Treatments" Sold Online

 

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Men looking online for "dietary supplements" to treat erectile dysfunction (ED) or enhance their sexual performance should beware: these products may contain prescription drugs or other undisclosed ingredients that can be harmful.

"The number of these problematic products available on the Internet appears to be increasing," says Michael Levy, director of the Food and Drug Administration's (FDA) Division of New Drugs and Labeling Compliance. The division is part of the Office of Compliance (OOC) in the agency's Center for Drug Evaluation and Research (CDER).