Ghana FDA orders recall of Arcan Bitters over drug adulteration

The Ghana Food and Drugs Authority (FDA) has ordered Unni Associates Company Limited to recall its Arcan Bitters product from the market within 14 days. Laboratory analysis revealed the 35% alcohol-by-volume beverage was adulterated with Sildenafil Citrate, a prescription-only medication used to treat erectile dysfunction and pulmonary arterial hypertension.

Because Arcan Bitters is registered as a food product rather than a medicine, the undeclared presence of the drug violates regulatory standards. The FDA warned that Sildenafil Citrate can interact with other medications to cause sudden drops in blood pressure, potentially leading to strokes or heart attacks. Exposure may also cause long-term health issues, such as loss of vision or hearing.

In response to the findings, the FDA has shut down the company’s manufacturing facility located in Parkoso, within the Asokore Mampong Municipality of the Ashanti Region. The Authority stated it will oversee the safe disposal of all recalled units and noted that failure to comply could lead to criminal prosecution under the Public Health Act, 2012.