A formal request for the recall of the erectile dysfunction dietary supplement was issued by the FDA after it discovered batches contained an undeclared active pharmaceutical ingredient (API).
SEI refused to recall the products leading to the FDA enlisting US Marshals to seize the batches to prevent more illegal Xiadafil from being sold.
Margaret Glavin, associate commissioner of the FDA’s Office of Regulatory Affairs, said: “Today’s seizure action shows that the FDA will take enforcement action to protect the public from dietary supplements that contain prescription drug ingredients that are potentially harmful to consumers.
“The FDA will not tolerate a company’s failure to take voluntary action to protect the public health after being given the opportunity by the FDA to do so.”
Chemical analysis of the batches revealed the presence of hydroxyhomosildenafil, a similar compound to the active ingredient in Viagra (sildenafil citrate), sildenafil.
Xiadafil is taken as an alternative to Viagra in the treatment of erectile dysfunction when the patient is advised not to take the latter because of medical conditions or possible interactions with other medications they are on.
Consequently the presence of hydroxyhomosildenafil could cause health problems. After performing the chemical analysis the FDA inspected SEI’s facility and warned the company of potential repercussions.
SEI stopped distributing the product and closed its website but refused to recall the product from the market. This was followed by the issuing of a “stop sale” by Florida state officials, which required SEI to keep contaminated batches found at its facility until further notification.
Two weeks later the FDA formally requested the recall of the affected batches. SEI did not act leading to the seizure by US Marshals.
In a case similar to SEI’s, EG Labs has initiated a nationwide recall of all batches of Viapro, a dietary supplement for treating erectile dysfunction.
Thio-methisosildenafil, which the FDA classes as an analog of sildenafil, was found following chemical analysis. The FDA informed EG Labs of the presence of a contaminant, leading to the company recalling the product.