FDA orders recall of Arcan Bitters within 14 days over undeclared sildenafil
The Food and Drugs Authority (FDA) has ordered Unni Associates Company Limited to recall its Arcan Bitters product from the market within 14 days.
The FDA said laboratory analysis found the alcoholic drink had been adulterated with Sildenafil Citrate, a prescription drug used to treat erectile dysfunction and pulmonary arterial hypertension.
The factory in Parkoso in the Asokore Mampong Municipality of the Ashanti Region, where the product is manufactured, has subsequently been closed down by the Authority.
“The laboratory analysis established that Arcan Bitters has been adulterated with Sildenafil Citrate, a Phosphodiesterase Type 5 (PDE5) inhibitor, which is an undeclared drug substance in the product,” the FDA said in a public release issued on Wednesday, September 2.
The Authority said Arcan Bitters is registered as a food product and an alcoholic drink and, therefore, must not contain any drug substance.
It cautioned that the presence of Sildenafil Citrate in the product poses serious health and safety risks to consumers.
According to the FDA, Sildenafil Citrate can interact with other medicines and cause a sudden drop in blood pressure, potentially resulting in stroke or heart attack.
The Authority further noted that the substance may cause long-term health complications, including loss of vision and hearing.
The FDA said the adulteration of food products is an offence under Section 100(3) of the Public Health Act, 2012 (Act 851).
It explained that the law prohibits the manufacture, advertising or sale of adulterated products or products that do not meet prescribed standards.