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Recall — Firm Press Release
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Freedom Trading Issues a Voluntary Nationwide Recall of Super Power, a Product Marketed as a Dietary Supplement to Support Male Sexual Performance, Due to Undeclared, Potentially Hazardous Active Ingredient
FOR IMMEDIATE RELEASE – January 24, 2013 – Woodbridge, NJ – D&S Herbals, LLC, d/b/a Freedom Trading is conducting a voluntary consumer recall of a product sold as a dietary supplement under the brand name of Super Power. This product was sold between August 2012 and January 2013 nationwide.
Finished product of Super Power was tested and found to contain trace amounts of an FDA-approved drug. Analytical tests conducted by independent labs of Super Power concluded that the products contained trace amounts 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 new drug.
This undeclared active ingredient poses 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. Additionally sildenafil may cause side effects such as, headaches and flushing.
The recalled products are in capsule form, packaged in two (2) count blister packs. The lot and expiration date can be found on the back of the package. The following lot is being recalled:
Freedom Trading has not received any reports of adverse events related to this recall.
We urge consumers who have purchased these products to immediately discontinue their use and contact their physician if they have experienced any problems that may be related to taking this product. The Company is advising consumers to return the product to their place of purchase. Consumers may also return products directly to Freedom Trading. Customers can call the Company at 866-780-6474 Monday through Friday from 9:00 am – 5:00 pm EST for instructions on the return and refund process.
Any adverse events or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm. Mail to address on the preaddressed form.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.