Super Power: Recall - Undeclared Ingredient
ISSUE: 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.
BACKGROUND: 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: L08108.
RECOMMENDATION: Consumers who have purchased these products are urged 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[01/24/2013 - Press Release - Freedom Trading]