Miami, Florida -based Distributor RFR, LLC is recalling certain Sangter Energy Supplement 3000 mg citing the presence of undeclared Sildenafil, the U.S. Food and Drug Administration said.
The recall involves lot #48656, Exp. 01/2025 of SANGTER Energy Supplement, 3000 mg, packaged in 7-count blister packs within a carton to the consumer level.
The tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in a 7-count blister pack within a carton, UPC 0 705632 523285. It was distributed through retail stores in the state of Florida and nationwide in the USA through its website from from February 1 to July 20, 2022.
The recall was initiated after an FDA analysis found the product to contain undeclared sildenafil.
Sildenafil is a phosphodiesterase or 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.
The agency noted that SANGTER with undeclared sildenafil 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. Adult males who use nitrates for cardiac conditions are at the most at risk from these products.
However, the company has not received any reports of adverse events related to the recalled drug to date.
Distributor RFR is arranging for the return of all recalled products.
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