Public Alert No. 021/2020-The Protein Shoppe recalls Red-E Male Enhancement Tablets Due to the Presence of Undeclared Sildenafil
November 13, 2020,
The National Agency for Food and Drug Administration and Control has been informed that the Protein Shoppe, LLC has announced a voluntary recall of all lots of Red-E Male Enhancement Tablets. The recall was initiated after an FDA analysis found that the product contains undeclared sildenafil, a Phosphodiesterase-5 (PDE-5) inhibitor that is used in the treatment of erectile dysfunction.
Sildenafil is an active ingredient in a different FDA-approved drug, but its use in the Red-E formulation was not approved by the FDA.
The undeclared PDE-5 inhibitor in the product may pose serious health risks to consumers with underlying medical issues. The substance may interact with prescription drugs such as nitroglycerin, resulting in a dangerous drop in blood pressure. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.
The product, Red-E (Male Enhancement tablet), is marketed as a male enhancement nutritional supplement, the product is a scored octagonal tablet with “Red” embossed on either side of the score line on one side of the tablet which is contained in small plastic bag with a black label stapled to it. The Red-E pill was sold online at RGV Protein Shoppe.
NAFDAC implores importers, distributors, healthcare providers and consumers to immediately stop the importation, distribution, sale and use of the Red-E Male Enhancement Tablets.
Members of the public already in possession of the product are implored to discontinue sale or use and handover stock to the nearest NAFDAC office.
Healthcare professionals and consumers are encouraged to report adverse events or side effects related to the use of the product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks), via email@example.com or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng