TOPIC: Schwinnng Capsules by STOP CLOPEZ CORP: Recall - Due to the Presence of Undeclared Nortadalafil
AUDIENCE: Consumer, Health Professional, Pharmacy
ISSUE: STOP CLOPEZ CORP is recalling one lot of Schwinnng capsules because 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.
Risk Statement: 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.
The product was distributed worldwide via Amazon at www.amazon.com.
To date, no adverse events have been reported.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The product being recalled is marketed as a dietary supplement for male sexual enhancement.
RECOMMENDATIONS:
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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.
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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.
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Consumers with questions regarding this recall can contact Camila Lopez, STOP CLOPEZ CORP, by 786-580-5100 or by e-mail 12clopezl@gmail.com.
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