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news.US-based dietary supplements manufacturer Green Plant has recalled its over the counter (OTC) dietary supplement Night Bullet, which is found to contain trace amounts of an analogue of an FDA-approved drug.
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According to FDA, the finished product contained trace amounts of Sulfohydroxyhomosildenafil and Aminotadalafil, which are analogues of sildenafil.
Sildenafil is an FDA-approved active pharmaceutical ingredient used to treat erectile dysfunction (ED), which makes this product an unapproved drug.
FDA said that these undeclared active ingredients pose a threat to consumers because sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels.
Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.
Additionally sildenafil may cause side effects such as, headaches and flushing.
FDA advised the firm to recall the product with batch lot number B43N032, UPC number 018505122233, and with expiration date October 2015.
The supplement was sold in the US between October 2012 and March 2013 to wholesalers and samples provided at trade shows.