FDA MedWatch - Alpha Male Plus Male Enhancer by Alpha Male Plus:

Recall - Due to Presence of Undeclared Tadalafil

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Alpha Male Plus Male Enhancer by Alpha Male Plus: Recall - Due to Presence of Undeclared Tadalafil AUDIENCE: Consumer, Health Professional, Pharmacy ISSUE: Alpha Male Plus is recalling all lots within expiry of Alpha Male Plus Male Enhancer fruit chews because FDA analysis has found the product to be tainted with tadalafil. Consumers with underlying medical conditions who take Alpha Male Plus Male Enhancer with undeclared tadalafil may experience serious health risks. For example, phosphodiesterase (PDE-5) inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Alpha Male Plus has not received any reports of adverse events related to this recall. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND:  Tadalafil is an ingredient in FDA approved products for the treatment of male erectile dysfunction in the family of drugs known as PDE-5 inhibitors. The presence of tadalafil in Alpha Male Plus Male Enhancer renders the product an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Alpha Male Plus was marketed as a dietary supplement for male sexual enhancement. RECOMMENDATIONS: Consumers/distributors/retailers that have product which is being recalled should stop using or return to place of purchase/discard/contact their doctor. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA