WEFUN's Dietary Supplement Capsules Recalled For Undeclared SildenafilSeptember 6, 2023
Brooklyn, New York-based WEFUN Inc is recalling 300 boxes of dietary supplement capsules to the consumer level for undeclared Sildenafil, the U.S. Food and Drug Administration said.
Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor or PDE-5 inhibitor found in FDA-approved products to treat male erectile dysfunction. Consumption of products with undeclared sildenafil is likely to interact with nitrates found in some prescription drugs, such as nitroglycerin. This may cause a significant drop in blood pressure that may be life threatening.
Nitrates are often taken to treat diabetes, high blood pressure, high cholesterol, or heart disease. Among the adult male population who are most likely to use WEFUN capsules, adult males who use nitrates for cardiac conditions are most at risk.
The recall was initiated after the agency in its analysis found the product to be tainted with sildenafil, which makes it an unapproved drug for which the safety and efficacy has not been established.
However, WEFUN has not received any reports of adverse events related to the recalled product to date.
The tainted WEFUN Capsules is marketed as a dietary supplement and is packaged in a blue cardboard box with 10 capsules. The affected WEFUN Capsule lot includes #18520168 and 09/30/2026. The capsules were distributed across the United States online through amazon.com and eshoponlineusa.com.
WEFUN is notifying its distributors and customers and is arranging for return of all recalled WEFUN capsules. Consumers/distributors/retailers are urged to stop using and return the affected product to place of purchase.
In recent recalls, Inmar Supply Chain Solutions, LLC in late August recalled various FDA regulated products, including dietary supplements, stored at its Arlington, Texas Facility citing poor conditions including rodents and higher than required heat.
For More Such Health News, visit rttnews.com
Source: Read Full Article