The products contain drugs that may be hazardous to consumers who use them
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Organic Herbal Supply is recalling all lots of several male and female sexual enhancement products after the FDA found they may be dangerous.
A complete list of the drugs is available on the FDA website.
Analysis by the FDAfound the products contain tadalafil a FDA-approved drug used as treatment for male Erectile Dysfunction (ED).
However, the presence of tadalafil in the recalled products renders it an unapproved drug for which safety and efficacy have not been established.
Consumer dangers
Using the recalled products my be dangerous because the undeclared active ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.
Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
There have been no reports of illness to date.
The male enhancement capsules are marketed as a dietary supplement for erectile dysfunction, are are packaged in 2, 4 and 10-count packages and sold nationwide.
The female products are packaged in 30-count packages and sold nationwide through Amazon.com and other online shopping sites.
What to do
Customers who purchased the recalled products should stop using them and return any unused portion directly to the company for a full refund.
Consumers may call 855-429-7328 between 10 a.m. and 5 p.m. (PST) for instructions on the return and refund process.
