FDA Alert: Florida Company’s Dietary Supplement Recalled for Containing Prescription Drug Ingredients

Company Announcement

FOR IMMEDIATE RELEASE – 04/22/2024– Hollywood, FL, US, 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.

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. To date, no adverse events have been reported.

This product is marketed as a dietary supplement for male sexual enhancement and is packaged and coded as follows:

SCHWINNNG Lot 2108 EXP 10/2024

The product was distributed Worldwide via Amazon at www.amazon.com.

STOP CLOPEZ CORP is notifying its customers by this press announcement of this recall release and is arranging for a return of all recalled products. 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.

Consumers with questions regarding this recall can contact Camila Lopez, STOP CLOPEZ CORP, by 786-580-5100 or by e-mail 12clopezl@gmail.com, between the hours of 10 a.m. and 5 p.m. Pacific Standard Time Monday-Friday, for instructions on the return and refund process. 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.

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