Stop Clopez Corp. has issued a voluntary worldwide recall of Schwinnng capsules due to the presence of undeclared Nortadalafil, an active drug ingredient used for treating male erectile dysfunction. The inclusion of Nortadalafil in Schwinnng capsules renders it an unapproved new drug, lacking established safety and efficacy, thereby necessitating a recall.
Risk Explanation: Nortadalafil, found in Schwinnng capsules, can potentially interact with nitrates present in certain prescription medications like nitroglycerin, leading to a significant drop in blood pressure that could be life-threatening. Individuals with conditions such as diabetes, high blood pressure, high cholesterol, or heart disease, who often use nitrates, are particularly at risk. Although no adverse events have been reported thus far among users, caution is advised.
Product Details: Marketed as a dietary supplement for male sexual enhancement, Schwinnng capsules are labeled as SCHWINNNG Lot 2108 EXP 10/2024. The product was distributed worldwide via Amazon.
Consumer Action: Consumers possessing Schwinnng products from the recalled lot are urged to cease usage immediately and either destroy them or return them to Stop Clopez Corp. Customers should include the blister pack foil (with any remaining pills), along with proof of purchase and their return address.
Contact Information: For inquiries regarding the recall, consumers can reach out to Camila Lopez at Stop Clopez Corp. via phone at 786-580-5100 or email at 12clopezl@gmail.com, Monday through Friday, between 10 a.m. and 5 p.m. Pacific Standard Time. Any related adverse reactions or quality issues should be reported to the FDA’s MedWatch Adverse Event Reporting program.
Regulatory Compliance: This recall is being conducted in collaboration with the U.S. Food and Drug Administration (FDA), ensuring adherence to regulatory standards and consumer safety protocols.
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