The Food and Drugs Authority (FDA) has ordered the recall of Arcan Bitters from the Ghanaian market after laboratory tests detected sildenafil citrate, a pharmaceutical ingredient commonly used to treat erectile dysfunction, in the alcoholic beverage.
The Authority has given the manufacturer, Unni Associates Company Limited, 14 days to recall the product and has shut down its manufacturing facility at Parkoso in the Asokore Mampong Municipality of the Ashanti Region.
According to the FDA, Arcan Bitters, which contains 35% alcohol by volume, is registered as a food product and alcoholic beverage and is therefore not permitted to contain pharmaceutical drug substances.
The FDA said laboratory analysis found the product had been adulterated with sildenafil citrate, a drug used to treat erectile dysfunction in men and pulmonary arterial hypertension.
The Authority warned that consuming the adulterated product could pose health risks, particularly because sildenafil can interact with certain medications and cause serious medical conditions.
The FDA said such interactions could result in serious health complications and also warned about possible vision and hearing problems associated with the substance.
The Authority said adulterating food products constitutes an offence under Section 100(3) of the Public Health Act, 2012 (Act 851).
It also said falsely labelling, packaging, selling or advertising food in a manner that is misleading constitutes an offence under the law.
The FDA has directed that all recalled Arcan Bitters be safely disposed of under its supervision.
It warned Unni Associates Company Limited that failure to comply with the recall directive could result in further regulatory action, including criminal prosecution.
The Authority has also advised consumers to immediately stop purchasing and consuming Arcan Bitters.
Retailers and distributors have been directed to remove the product from their shelves, while members of the public have been encouraged to report outlets that continue to sell it to the nearest FDA office.
The FDA said public cooperation would be necessary to ensure the product is removed from the market and to protect consumers from potential health risks.
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