Ashanti Region factory shut down as authorities warn of stroke, heart attack risk from unauthorized Sildenafil Citrate in popular drink
The Food and Drugs Authority (FDA) has ordered Unni Associates Company Limited to pull its Arcan Bitters product from shelves nationwide within 14 days, after laboratory tests revealed the alcoholic drink was secretly adulterated with a prescription erectile dysfunction drug.
The Authority has also shut down the company’s manufacturing plant at Parkoso, in the Asokore Mampong Municipality of the Ashanti Region, where the product is produced. The FDA said it will personally oversee the safe disposal of all recalled units and cautioned that the company faces further regulatory sanctions, including criminal prosecution, if it fails to comply with the directives.
The regulatory clampdown follows laboratory analysis of Arcan Bitters (35% Alc/Vol), which the FDA said established that the product “has been adulterated with Sildenafil Citrate, Phosphodiesterase Type 5 (PDE5) inhibitor, which is an undeclared drug substance in the product.”
Sildenafil Citrate is a prescription-only medicine used to treat erectile dysfunction in men, as well as pulmonary arterial hypertension — a substance with no business being in a bottle registered and sold as an ordinary alcoholic beverage.
According to the Authority, the adulteration constitutes an offence under Section 100(3) of the Public Health Act, 2012 (Act 851), which “prohibits the manufacture, advertising or offer for sale of any adulterated product, or a product that is different from the nature, substance and quality of the prescribed standard.”
The FDA noted it is similarly “an offense to manufacture, label, package, sell or advertise a food product in a manner that is false, misleading, or deceptive as regards its character, nature, value additives, quality, substance and composition”, a standard the Authority says Arcan Bitters failed to meet.
The Authority stressed that Arcan Bitters “is registered with the Authority as a Food Product (an alcoholic drink) and must not contain any drug substance,” making the presence of the ED medication a clear breach of its own registration.
The FDA warned that the undeclared drug substance “poses serious health and safety risks to the public.” Sildenafil Citrate, it explained, “can interact with other medicines to cause sudden drop in blood pressure, which may lead to stroke and heart attack.”
Beyond the immediate danger of drug interactions, the Authority cautioned that Sildenafil Citrate “may cause long-term health problems, including loss of vision and hearing.”
The FDA has strongly advised the public to refrain from purchasing or consuming Arcan Bitters. It further called on the public, retailers, and distributors to comply with the recall directive and report anyone still offering the product for sale to the nearest FDA office, to ensure the product is completely removed from trade.
The Authority said members of the public can reach it to report unhygienic practices or any other activities that may compromise public health and safety through its official contact channels.
