The Food and Drugs Authority (FDA) has ordered Unni Associates Company Limited to immediately recall its alcoholic beverage, Arcan Bitters, from the market within 14 days following the discovery of undeclared prescription medication in the product.
The regulatory body has also shut down the manufacturing facility located at Parkoso in the Asokore Mampong Municipality of the Ashanti Region. Laboratory tests conducted on the 35% Alc/Vol drink revealed that it had been adulterated with Sildenafil Citrate, a Phosphodiesterase Type 5 (PDE5) inhibitor commonly used to treat erectile dysfunction and pulmonary arterial hypertension.
According to the Authority, the inclusion of an undeclared pharmaceutical ingredient in a registered food product poses severe health risks to consumers.
“The presence of Sildenafil Citrate in a food product poses serious health and safety risks to the public. Sildenafil Citrate can interact with other medicines to cause sudden drop in blood pressure, which may lead to stroke and heart attack,” the FDA stated in an official public notice. The regulator added that exposure to the substance “may cause long-term health problems, including loss of vision and hearing”.
The FDA emphasized that the adulteration breaches Section 100 (3) of the Public Health Act, 2012 (Act 851), which forbids the production, sale, or advertisement of adulterated products or goods that deviate from prescribed safety standards. Furthermore, labeling and packaging a food item in a misleading or deceptive manner constitutes a regulatory offense.
“Arcan Bitters appears to have flouted all these requirements and more. Arcan Bitters is registered with the Authority as a Food Product (an alcoholic drink) and must not contain any drug substance,” the statement noted.
The Authority confirmed it will supervise the safe disposal of all recalled products and warned Unni Associates Company Limited that failure to comply with the directive will result in further sanctions, including criminal prosecution.
Distributors, retailers, and members of the public have been urged to refrain from buying or consuming the product and to report anyone offering Arcan Bitters for sale to the nearest FDA office.
