Natural Wellness, Inc. just issued a nationwide voluntary recall of <"https://www.yourlawyer.com/practice_areas/defective_drugs">MasXtreme Capsules, Marketed As a Dietary Supplement, the U.S. Food & Drug Administration (FDA) announced.
Natural Wellness is warning consumers not to purchase or consume the product known as MasXtreme, Lot# 911035, which is being marketed as a dietary supplement and which contains undeclared amounts of Aildenafil, as well as the drug Phentolamine.
Phentolamine is an alpha-adrenergic blocker. Common side effects of Phentolamine include arrhythmia (abnormal heart rhythm) and tachycardia (rapid heart beat).
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.
MasXtreme is sold in blister packs containing one capsule. The product is distributed Nationwide by Natural Wellness Inc and is being promoted for increasing desire and sexual performance and 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 Highway; Suite 107; Deerfield Beach, Florida; 33441. Consumers with questions regarding this recall may contact the company at 1-954-570-6662, Monday through Friday, from 8:00 am to 4:00 pm. Consumers who have purchased this product and have medical concerns are urged to 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. Online: www.fda.gov/MedWatch/report.htm. Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form. Fax: 1-800-FDA-0178.
