Steam Dietary Supplement

August 24, 2009

Audience: Consumers, pharmacists

[UPDATED 08/24/2009] Nutracoastal has found by lab analysis that Lot 90260 contains Tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction, making Steam an unapproved drug. The lot number for the 07/28/2009 recall was 80214.

[Posted 07/29/2009] Nutracoastal Trading LLC and FDA notified healthcare professionals and consumers of a nationwide recall of the company's dietary supplement product sold under the name Steam. Lab analysis by FDA found that the product contains sulfoaildenafil, an analog of sildenafil. Sildenafil is an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making Steam an unapproved drug. The undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Additionally, the product may cause side effects, such as headaches and flushing.

The recalled product was distributed in white plastic bottles to retail stores nationwide. Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

[08/24/2009 - Press Release - Nutracoastal Trading LLC]
[07/28/2009 - Press Release - Nutracoastal Trading LLC]

 

    

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