Natural Wellness, Inc. just issued a nationwide, voluntary recall of its <“https://www.yourlawyer.com/practice_areas/defective_drugs”>MasXtreme Capsules, which are marked as a dietary supplement, the U.S. Food and Drug Administration (FDA) just announced. The recall involves 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 the recalled MasXtreme Capsules an unapproved new drug.
FDA advises that the MasXtreme Capsules pose a threat to consumers because aminotadalafil 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. The product is sold without medical a prescription. To date, no adverse events have been reported.
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 954-570-6662 Monday through Friday, from 8:00 am to 4:00 pm. Consumers who have purchased this product and have medical concerns should consult their health care providers.
Adverse reaction or quality problems experienced with the use of this recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax: Online at www.fda.gov/MedWatch/report.htm; regular mail, use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm and mail to the address on the pre-addressed form; or by fax to 1-800-FDA-0178.
