STOP CLOPEZ CORP is voluntarily recalling one lot of Schwinnng capsules to the consumer level. FDA analysis has found the Schwinnng products to contain Nortadalafil. Nortadalafil is an active drug ingredient known for the treatment of male erectile dysfunction. The presence of Nortadalafil in Schwinnng capsules makes
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it an unapproved new drug for which the safety and efficacy have not been established and, therefore subject to recall. The product was distributed Worldwide via Amazon at www.amazon.com. To date, no adverse events have been reported.
The Schwinnng products contain Nortadalafil, which 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 this product, adult males who use nitrates for cardiac conditions are most at risk.
This product is marketed as a dietary supplement for male sexual enhancement and is packaged and coded as follows:
SCHWINNNG Lot 2108 EXP 10/2024
STOP CLOPEZ CORP is notifying its customers by this press announcement of this recall release and is arranging for a return of all recalled products. Consumers that have a Schwinnng product that is being recalled should stop using and destroy / return if desired to STOP CLOPEZ CORP. Schwinnng products must include the blister pack foil (with any pills remaining) containing all lot codes and receipt of proof of purchase, and your return address.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Link to FDA Advisory
If you are experiencing symptoms after eating this product it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist seek medical attention.
Company name: STOP CLOPEZ CORP
Brand name: Schwinnng
Product recalled: Herbal Dietary Supplement
Reason of the recall: Product is tainted with Nortadalafil
FDA Recall date: April 23, 2024
Source:
www.fda.gov
