The US Food and Drug Administration (FDA) announces that 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 it an unapproved new drug for which the safety and efficacy have not been established and, therefore subject to recall.
The product contains 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. To date, no adverse events have been reported. The product is marketed as a dietary supplement for male sexual enhancement and is packaged and coded as follows:
SCHWINNNG Lot 2108 EXP 10/2024
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/stop-clopez-corp-issues-voluntary-worldwide-recall-schwinnng-capsules-due-presence-undeclared
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by FDA, and was posted on the Drug Office website since 27 Dec 2023, with the latest update posted on 6 Feb 2024.
Ends/Wednesday, Apr 24, 2024
Issued at HKT 15:45
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