The Food and Drugs Authority (FDA) has ordered the immediate recall of Arcan Bitters, an alcoholic beverage manufactured by Unni Associates Company Limited, after laboratory analysis found that the product had been adulterated with Sildenafil Citrate, an undeclared drug substance.
The FDA has directed the company to withdraw the product from the market within 14 days.
The manufacturing facility located at Parkoso in the Asokore Mampong Municipality of the Ashanti Region has also been closed down as part of the regulatory action.
According to the FDA, Arcan Bitters is registered as a food product and alcoholic drink and therefore must not contain any pharmaceutical drug substance.
Sildenafil Citrate is a prescription medicine commonly used to treat erectile dysfunction in men and pulmonary arterial hypertension.
The FDA warned that the presence of the drug in an alcoholic beverage poses serious health and safety risks, particularly because it may interact with other medicines and cause a sudden drop in blood pressure, potentially leading to serious complications including stroke and heart attack.
The Authority also cautioned that sildenafil may be associated with vision and hearing problems.
The FDA has warned Unni Associates Company Limited that failure to comply with the recall directive could result in further regulatory sanctions, including criminal prosecution.
The Authority says it will oversee the safe disposal of the recalled products and has urged consumers to refrain from purchasing or consuming Arcan Bitters.
Retailers and distributors have also been directed to remove the product from sale and report anyone continuing to offer it for sale to the nearest FDA office.
By: Bernard Mensah
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