FDA MedWatch - Sangter Energy Supplement by Distributor RFR

Recall - Due to Presence of Undeclared Sildenafil

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Sangter Energy Supplement by Distributor RFR: Recall - Due to Presence of Undeclared Sildenafil AUDIENCE: Consumer, Health Professional, Pharmacy ISSUE: DISTRIBUTOR RFR, LLC is recalling lot #48656 of SANGTER Energy Supplement, 3000 mg, because FDA analysis has found the product to contain undeclared sildenafil. Sildenafil is a phosphodiesterase (PDE-5) inhibitor found in FDA-approved products for the treatment of male erectile dysfunction. The presence of sildenafil in SANGTER makes it an unapproved new drug for which the safety and efficacy has not been established and, therefore subject to recall. Risk Statement: Use of SANGTER with undeclared sildenafil may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are at the most at risk from these products. To date, DISTRIBUTOR RFR, LLC 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: The tainted product is marketed as a dietary supplement for male sexual enhancement. RECOMMENDATIONS:  All consumers are urged to stop consuming the product marked with this lot, and to contact their physician or health care provider if they have experienced any problems that may be related to taking or using this medication. Consumers with questions about this recall can contact the company. Consumers and health professionals 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. Follow us on Twitter at @FDAMedWatch

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