The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public of a voluntary recall of one lot of Schwinnng capsules by Stop Clopex Corp, due to the undeclared presence of Nortadalafil. The product was found to contain Nortadalafil, during an FDA analysis.
Nortadalafil is an active drug ingredient known for the treatment of male erectile dysfunction. The presence of Nortadalafil in Schwinnng capsules makes it an unapproved new drug for which the safety and efficacy have not been established and, therefore subject to recall.
Schwinnng Herbal Dietary Supplement capsules are marketed and sold online as a dietary supplement for male sexual enhancement.
Risk Statement
Undeclared Nortadalafil in the product 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. The adult male population who are most likely to use this product with nitrates (in prescription drugs for cardiac conditions), are most at risk.
Product Details
The details of the product are as follows:
Product Name | Schwinnng Herbal Dietary Supplement |
Product Manufacturer | STOP CLOPEZ CORP |
Batch number | 2108 |
Expiry date | 10/2024 |
Product photo
Please, note that this product is not registered by NAFDAC. It is marketed and sold online.
Members of the public in possession of the above product are advised to discontinue sale or use and submit stock to the nearest NAFDAC office.
If you have this product, please DO NOT use it. If you, or someone you know that is using this product, or suffered any adverse reaction/event after the use, you are advised to seek immediate medical advice from a qualified healthcare professional.
Healthcare professionals and consumers are advised to report any suspicion of sale of substandard and falsified medicines to the nearest NAFDAC office, or call NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products 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
NAFDAC……….Customer-focused, Agency-minded!!!