Natural Wellness, Inc. Issues Recall of Masxtreme Capsules, Marketed As a Dietary Supplement
On March 30, 2010, the U.S. Food and Drug Administration (FDA) issued the following advisory regarding a voluntary nationwide recall of Masxtreme, an over-the-counter dietary supplement that has been found to contain a form of a drug which could cause serious cardiac health risks for users.
In addition, the FDA also ordered an August 2010 recall of Masxtreme capsules that were tainted with the same FDA-approved drug.
Natural Wellness is warning consumers not to purchase or consume the product known as MasXtreme, Lot# 911035. This product which is being marketed as a dietary supplement contains undeclared amounts of Aildenafil, as well as the drug Phentolamine which is an alpha-adrenergic blocker. Aildenafil is close in structure to Sildenafil and is expected to possess a similar pharmacological and adverse event profile.
Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED). 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. This product is being promoted for increasing desire and sexual performance. The product is sold without medical prescription.
Consumers who have purchased MasXtreme tablets are urged to immediately discontinue their use and return the product to their place of purchase or directly to Natural Wellness Inc. at 440 S Federal Hwy, Suite 107, Deerfield Beach, FL 33441. Consumers with questions regarding this recall may contact the company at 954-570-6662 Monday through Friday 8 am to 4 pm. Consumers who have purchased this product and have medical concerns should consult with their health care providers.
Adverse reaction or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax. The form for regular mail can be found at this link.
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