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MasXtreme Capsules (Natural Wellness) - product contains undeclared drug ingredient

Wed, 08/25/2010 - 9:30am
U.S. Food & Drug Administration

[UPDATED 08/25/2010] Natural Wellness notified consumers it is conducting a nationwide voluntary recall of MasXtreme, Lot # 907043, UPC 094922300805. Laboratory analysis conducted by FDA determined the product contains undeclared amounts of Aminotadalafil, an analog of tadalafil. Tadalafil is an FDA-Approved drug used to treat erectile dysfunction (ED), making MasXtreme an unapproved new drug.

Natural Wellness and FDA notified consumers that MasXtreme, a product sold as a dietary supplement contains aildenafil close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile as well as the drug phentolamine which is an alpha-adrenergic blocker. This may pose a threat to consumers because aildenafil 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. Common side effects of Phentolamine include arrhythmia (abnormal heart rhythm) and tachycardia (rapid heart beat).

MasXtreme is sold in blister packs containing one (1) capsule. The product is distributed nationwide by Natural Wellness Inc. Consumers who have purchased MasXtreme capsules are urged to immediately discontinue their use.

Healthcare professionals and consumers 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

 

[08/24/2010 - Firm Press Release - Natural Wellness]

[03/30/2010 - Firm Press Release - Natural Wellness]

    

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