On April 22, 2024, STOP CLOPEZ CORP, a distributor of health supplements based in Hollywood, FL, announced a voluntary recall of a specific lot of Schwinnng male enhancement capsules. The recall was initiated following an analysis by the Food and Drug Administration (FDA) which detected the presence of Nortadalafil in the capsules. Nortadalafil, a compound used in the treatment of male erectile dysfunction, is not an approved ingredient in dietary supplements and its presence in Schwinnng capsules renders them an unapproved new drug.
Background and Details of the Recall
Schwinnng capsules are marketed as dietary supplements intended for male sexual enhancement. The specific lot affected by this recall is Lot 2108, with an expiration date of October 2024. The product has been distributed worldwide and is available for purchase on major online platforms including Amazon.
The FDA’s discovery of Nortadalafil in these capsules is significant because it has not been established as safe and effective for over-the-counter use. Moreover, Nortadalafil may pose serious health risks, particularly to individuals who are on medications containing nitrates, such as nitroglycerin, commonly prescribed for heart conditions. Interaction between Nortadalafil and nitrates can lead to a severe drop in blood pressure, potentially resulting in life-threatening situations.
As of the date of the recall, no adverse events or health issues have been reported in connection with the Schwinnng product. Nevertheless, the presence of an unapproved pharmaceutical compound in a dietary supplement is cause for concern and immediate corrective action.
Distribution and Consumer Information
The recalled product, packaged under the label SCHWINNNG with Lot 2108, was distributed globally through online sales, making the scope of the recall extensive. Consumers who have purchased this product are advised to immediately cease using it and dispose of it or return it to STOP CLOPEZ CORP. The company has provided detailed instructions for consumers to return the product, including the requirement to return the blister pack foil with any remaining capsules and a receipt as proof of purchase.
STOP CLOPEZ CORP has undertaken to notify customers directly via this press announcement and is coordinating the return and refund process for all recalled products. The company has also set up a contact point for consumer inquiries, managed by Camila Lopez, available by phone or email during business hours from Monday to Friday.
Health Advisory and Reporting of Adverse Events
Health professionals advise consumers who have used the Schwinnng capsules to monitor their health closely and consult a healthcare provider if they experience any symptoms that could be related to the use of this product. Symptoms of a significant drop in blood pressure include dizziness, lightheadedness, fainting, or even heart attack and stroke in severe cases.
Consumers and health professionals are also encouraged to report any adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting program. This can be done online, by regular mail, or fax, thereby contributing to the safety monitoring of this product.
Regulatory Oversight and Compliance
This recall is being conducted with the knowledge and oversight of the U.S. Food and Drug Administration. The FDA’s role is crucial in ensuring the safety and efficacy of drugs and dietary supplements available in the U.S. market. Their findings and subsequent actions demonstrate the regulatory framework in place to protect public health from unapproved and potentially dangerous substances in consumer products.
The case of the Schwinnng capsules underscores the importance of rigorous compliance with FDA regulations by manufacturers and distributors of dietary supplements. It also highlights the challenges of regulating products that are sold online and distributed globally, which may not always undergo thorough regulatory scrutiny before reaching consumers.
Conclusion
The voluntary recall of Schwinnng capsules by STOP CLOPEZ CORP is a proactive measure to safeguard consumer health following the discovery of an unapproved substance in the product. It reflects the ongoing challenges faced by regulatory authorities and companies in the health supplement industry to ensure the safety and efficacy of their products. As the situation evolves, it will be important for all stakeholders, including consumers, health professionals, and regulators, to remain vigilant and responsive to ensure public health and safety.
This recall serves as a reminder of the critical role of regulatory oversight and the need for continuous monitoring and enforcement to protect consumers from potentially harmful products.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Link to FDA Advisory
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/stop-clopez-corp-issues-voluntary-worldwide-recall-schwinnng-capsules-due-presence-undeclared
