Recall -- Firm Press Release
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Natural Wellness, Inc. Issues a Nationwide Voluntary Recall of Masxtreme Capsules, Marketed as a Dietary Supplement
FOR IMMEDIATE RELEASE - August 24, 2010 - Natural Wellness is announcing that it is conducting a nationwide voluntary recall of MasXtreme, Lot # 907043, UPC 094922300805. Laboratory analysis conducted by FDA has 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 MasXtreme an unapproved new drug.
Risk Statement: FDA advises that this poses 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 (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. 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 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. 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.
This recall is being conducted in cooperation with the U.S. Food and Drug Administration (FDA).