TOPIC: Sustain and Schwinnng Dietary Supplement Capsules by Today The World: Recall - Due to the Presence of Undeclared Tadalafil and Nortadalafil
AUDIENCE: Consumer, Health Professional, Pharmacy
ISSUE: “Today The World” is recalling two lots, BTH:230551 and BTH: 230571, of Sustain herbal dietary supplement capsules and one lot, Lot 2108 of Schwinnng capsules because 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.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: These tainted products are marketed as dietary supplements for male sexual enhancement.
RECOMMENDATIONS:
-
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.
-
Consumers that have the recalled lots of Sustain or Schwinnng should stop using and destroy them/return if desired to “Today The World”. 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.
|
