Natural Wellness Inc. Recalling MasXtreme Capsules

• Date: April 01, 2010
• Source: Admin

Natural Wellness is informing its consumers to restrain from buying or consuming its well known dietary supplement, MasXtreme Capsules, as the product contains undeclared drug ingredient.

30th march, 2010, FDA notified consumers about presence of undeclared amount of aildenafil and Phentolamine, an alpha-adrenergic blocker, in MasXtreme capsules which can cause adverse effects on human health.

Possible Adverse Effects on Human Health

Structurally, aildenafil is close to Sildenafil and is assumed to have same pharmacological and adverse event profile. Sildenafil is an active pharmaceutical ingredient present in an FDA approved drug used for erectile dysfunction (ED). Sharing a similar structure, Aildenafil interferes functions of nitrate and can create a serious health hazards for patients with diabetes, high blood pressure, high cholesterol, or heart disease as they take medicine consists of nitrate. Patients with mentioned diseases can experience lower blood pressure to dangerous level. Additionally, Phentolamine can cause arrhythmia (abnormal heart rhythm) and tachycardia (rapid heartbeat).

Distributed Nationwide by Natural Wellness Inc., MasXtreme comes in blister packs containing one (1) capsule. Consumers buy the product for increasing sexual desire and performance and they can buy the medicine without medical prescription.

Stop Using, Consult Doctor and Return the Medicine

Natural Wellness Inc. together with FDA has informed the consumers to immediately discontinue the usage of the medicine and to return the medicine to their place of purchase or to the Natural Wellness Inc. office directly at 440 S Federal Hwy, Suite 107, Deerfield Beach, FL 33441.

Person experiencing adverse effect should consult doctor and should report any adverse reaction or quality problems experienced with the use of this product 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 . Send mail to address on the pre-addressed form.

Fax:1-800-FDA-0178.

Source:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm206791.htm

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