MedWatch - Steam Dietary Supplement: Nationwide recall because found to contain undeclared drug ingredient, an analog of sildenafil

[FDA MedWatch <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: MedWatch - Steam Dietary Supplement: Nationwide recall because found to contain undeclared drug ingredient, an analog of sildenafil

Steam Dietary Supplement

Audience: Consumers, pharmacists

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].

Read the complete MedWatch Safety summary including a link to the firm press release and photo of product, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm174339.htm

 

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420