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West Coast Nutritionals Dietary Supplement Products: Recall - Undeclared Drug Ingredient

Mon, 05/21/2012 - 7:31am
U.S. Food & Drug Administration

AUDIENCE: Consumer

ISSUE: West Coast Nutritionals, Ltd. is conducting a recall of all lots of their dietary supplements Firminite, Extra Strength Instant Hot Rod, and Libidron to the consumer level. An FDA lab analysis of Firminite was found to contain undeclared Tadalafil. Tadalafil is an active ingredient of an FDA approved drug for Erectile Dysfunction (ED), making these products unapproved new drugs. All lots of the affected products contain undeclared Tadalafil, which can pose a serious risk to health because Tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA advises that Tadalafil may cause side effects such as headaches and flushing. The FDA is aware of one consumer complaint with an adverse event.

BACKGROUND: The affected products may have been ordered online at www.firminite.com, www.instanthotrodextrastrength.com, www.libidron.com, or www.amazon.com and were distributed to customers and retailers nationwide and worldwide. These products are marketed as dietary supplements intended for use as a male enhancement product.

RECOMMENDATION: West Coast Nutritionals is notifying its customers and retailers by email and/or phone to return all recalled products. All customers and retailers that have any of these products which are being recalled should stop using these products and return any unused products West Coast Nutritionals. See the Press Release for additional return information.

 

[05/18/2012 - Press Release - West Coast Nutritionals]

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