Nigerian Public Alert 77: The National Agency for Food and Drug Administration and Control (NAFDAC) received a notification that Best Supplements Best Prices Company is voluntarily recalling all lots of WAP Sensual Enhancement capsules to the consumer level following the detection of undeclared pharmaceutical ingredients by the U.S Food and Drug Administration.
Laboratory analysis by the US FDA revealed that the product contained undeclared sildenafil, tadalafil, and flibanserin, which were not mentioned on the product label. Such substances may include phosphodiesterase type-5 (PDE-5) inhibitors or related compounds commonly used for the treatment of erectile dysfunction
Sildenafil and tadalafil are ingredients in FDA-approved prescription drugs used to treat erectile dysfunction. These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Flibanserin is the active ingredient in an FDA-approved prescription drug used to treat low sexual desire in women. Flibanserin can cause drowsiness, sedation, dangerously low blood pressure, and fainting, especially when combined with alcohol.
Risk Statement
The presence of undeclared medicinal ingredients in products marketed as dietary supplements or herbal products poses a significant health risk to consumers, particularly individuals with underlying medical conditions or those taking prescription medications.
Product Information
The details of the recalled product are as follows;
Product Name: WAP Sensual Enhancement capsules
Manufacturer: Best Supplement Best Prices Company
Affected lots: All lots
Product Category: Sexual Enhancement Supplement
Country of Origin: Unknown (The product is marketed and distributed online in the U.S. through eBay)
NAFDAC implores members of the public in possession of the above product to stop the sale or use and hand it over to the nearest NAFDAC office.
NAFDAC remains committed to safeguarding public health and will continue surveillance activities to ensure the quality, safety, and efficacy of medicines, medical devices, and other regulated products circulating in Nigeria.
Consumers are also encouraged to report compromised products (medicines or medical devices) to the nearest NAFDAC office, NAFDAC on 0800-162-3322, or via email: sf.alert@nafdac.gov.ng
Healthcare professionals and patients should report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng, or via the Med-safety application available for download on Android and IOS stores, or via e-mail on pharmacovigilance@nafdac.gov.ng
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