Wilmington, Delaware-based Ultra Supplement LLC is recalling certain Sustango capsules citing the presence of undeclared Tadalafil, an active pharmaceutical ingredient, the U.S. Food and Drug Administration said.
The product is marketed as a dietary supplement for male enhancement.
The recall was initiated after Ultra Supplement was notified by Amazon that laboratory analysis has found the product to be tainted with tadalafil. It is an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase or PDE-5 inhibitors.
According to the agency, the presence of tadalafil in Sustango makes this product an unapproved drug for which the safety and efficacy has not been established and therefore, subject to recall.
The recall involves Sustango capsules packaged in 10-count blisters packaged in a carton, ASIN X0024468I9, to the consumer level. The affected product comes with lot number DAP272109, and expiry date of 4/1/26.
The product was distributed through the internet and fulfilled by Amazon at www.amazon.com nationwide in the USA.
The FDA in December 2020 had warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients.
Consumers with medical issues who take Sustango capsules with undeclared tadalafil may experience health risks. PDE-5 inhibitors may interact with nitrates found in some prescription drugs, such as nitroglycerin, lowering blood pressure to dangerous levels that may be life-threatening.
Consumers with diabetes, high blood pressure, or heart disease often take nitrates.
Howeverm Ultra Supplement has not received any reports of adverse events related to the recalled product to date.
In similar incidents, MKS Enterprise LLC last week called back Dose Vital VIP Vital Honey citing the presence of undeclared Tadalafil.
In early July, Loud Muscle Science, LLC recalled certain Launch Sequence products in the U.S. and Canada for the same conern.
For More Such Health News, visit rttnews.com
Source: Read Full Article