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MIL-OSI USA: Today The World Issues Voluntary Nationwide Recall of All Lots of Sustain and Schwinnng brand Dietary Supplement Capsules Due to the Presence of Undeclared Tadalafil and Nortadalafil

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Source: US Food and Drug Administration

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:

Recall Reason Description

Products contain undeclared Tadalafil and Nortadalafil

Company Name:
Today the World
Brand Name:

Brand Name(s)

Sustain, Schwinnng

Product Description:

Product Description

Sustain and Schwinnng brand male enhancement capsules


Company Announcement

FOR IMMEDIATE RELEASE – February 2, 2024 – VANCOUVER, WA, “Today The World” is voluntarily recalling two lots of Sustain herbal dietary supplement capsules and one lot of Schwinnng capsules to the consumer level. FDA analysis has found the products to contain undeclared Tadalafil and Nortadalafil (structurally similar to Tadalafil). Tadalafil and Nortadalafil are active drug ingredients known for treatment of male erectile dysfunction. The presence of Tadalafil and Nortadalafil in Sustain capsules and Schwinnng capsules makes them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.

Risk Statement: Consumption of products with undeclared tadalafil or nortadalafil 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.

These tainted products are marketed as dietary supplements for male sexual enhancement and are packaged and coded as follows:

SUSTAIN: BTH:230551, EXP:12.05.2026, BTH: 230571, EXP: 14.05.2026

SCHWINNNG Lot 2108 EXP 10/2024

Products were distributed via Amazon at www.amazon.com and www.sustainformula.com and www.schwinnng.com.nationwide in the USA.

Today The World is notifying its customers by this press announcement of this recall release and is arranging for return/replacement etc. of all recalled products. Consumers that have Sustain or Schwinnng which is being recalled should stop using and destroy them/return if desired to Today The World, 11954 NE Glisan St # 405 Portland OR 97220. The Sustain and 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 Today The World by e-mail info@sustainformula.com and info@schwinnng.com or customers can call 888-767-4889 or text 360-747-7411, 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.

Today The World. is committed to improving its products and avoiding future recall issues by sourcing higher quality raw ingredients and expanding testing. Today The World. promises its customers the highest possible quality and welcomes the recall process as further evidence of our commitment to our brands, products and consumers.

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.


Company Contact Information


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