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Stop Clopez Corp voluntarily recalls herbal dietary supplement
After an FDA analysis found that the male sexual enhancement supplements contained Nortadalafil, the company issued a voluntary recall.
On April 23, 2024, the United States FDA published a voluntary recall from Stop Clopex Corp regarding its Schwinnng capsules. According to the recall, the product was found to contain Nortadalafil, an active drug ingredient, during an FDA analysis.
Dietary supplements are only loosely regulated across the United States. Unlike pharmaceutical products with active drug ingredients and proven indications, nutritional supplements do not have to undergo the same level of scrutiny, including preclinical research, clinical trials, and post-market analysis.
That said, the US FDA still samples certain supplements periodically to ensure they do not contain harmful compounds or pharmaceutical ingredients.
In this case, the FDA was conducting an analysis of the Schwinnng capsules when it detected the presence of Nortadalafil, an active ingredient used to treat erectile dysfunction. According to Universal Biologicals, the compound is also known as demethyl Tadalafil and acts as a PDE5 inhibitor. The drug is currently being sold under the brand name Cialis for erectile dysfunction and Adcirca to treat pulmonary arterial hypertension.
Despite being FDA-approved, Nortadalafil use without the guidance of a licensed healthcare professional may cause adverse reactions in patients. Interactions with nitrites in prescription drugs may cause life-threateningly low blood pressure levels. Patients taking medication for diabetes, high blood pressure, high cholesterol, or heart disease are likely to be taking prescription drugs with nitrites, making them at risk for adverse events.
While no adverse events have been reported with the recalled lot (Lot 2108, which expires 10/2024), the FDA warns consumers to discontinue use. Stop Clopez Corp is refunding consumers and offering refund details via phone or email.
Although this recall is recent, it is not the first time Nortadalafil has been identified in dietary supplements. According to the FDA, the company had a similar issue in December 2023, which was also prompted by an FDA laboratory analysis and resulted in an FDA advisory warning consumers to avoid the product.
Additionally, Drugs.com notes that, in February 2024, Schwinnng capsules were also recalled for the presence of Nortadalafil.
These continual and repetitive instances of tainted products suggest a need for more comprehensive dietary supplement regulation.
