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 factory in the Ashanti Region that manufactures the product has also been closed down.
In a statement issued on Wednesday, the FDA said it will conduct a safe disposal of the recalled products and warned the company that it risks further regulatory sanctions, including criminal prosecution, if it fails to abide by the directives.
The regulatory action follows laboratory analysis conducted on Arcan Bitters (35% Alc/Vol), manufactured by Unni Associates Company Limited at Parkoso, in the Asokore Mampong Municipality of the Ashanti Region. The analysis established that the product had been adulterated with Sildenafil Citrate, a Phosphodiesterase Type 5 (PDE5) inhibitor, an undeclared drug substance. Sildenafil Citrate is a prescription-only medicine used to treat erectile dysfunction in men, as well as pulmonary arterial hypertension.
The FDA said the adulteration of food products is an offence under Section 100(3) of the Public Health Act, 2012 (Act 851), which prohibits the manufacture, advertising or sale of any adulterated product, or one that differs from its stated nature, substance and quality. It said it is similarly an offence to manufacture, label, package, sell or advertise a food product in a manner that is false, misleading or deceptive regarding its character, nature, value, additives, quality, substance and composition, and that Arcan Bitters appeared to have flouted all of these requirements.
The Authority said Arcan Bitters is registered as a food product, specifically an alcoholic drink, and must not contain any drug substance. It said the presence of Sildenafil Citrate poses serious health and safety risks, as the substance can interact with other medicines to cause a sudden drop in blood pressure, potentially leading to stroke and heart attack. It added that the drug may also cause long-term health problems, including loss of vision and hearing.
The FDA strongly advised the public to refrain from purchasing or consuming the product, and urged retailers and distributors to comply with the recall directive. It further asked members of the public to report anyone found selling Arcan Bitters to the nearest FDA office to ensure the product's complete removal from trade.
