The Food and Drugs Authority (FDA) has ordered Unni Associates Company Limited to recall its Arcan Bitters product from the Ghanaian market within 14 days after laboratory analysis detected the presence of an undeclared drug substance.
The FDA has also closed down the company’s manufacturing facility at Parkoso in the Asokore Mampong Municipality of the Ashanti Region.
According to the FDA, laboratory analysis of Arcan Bitters, an alcoholic beverage with an alcohol content of 35% Alc/Vol, established that the product had been adulterated with Sildenafil Citrate, a Phosphodiesterase Type 5 (PDE5) inhibitor.
Sildenafil Citrate is a prescription medicine used in the treatment of erectile dysfunction in men and pulmonary arterial hypertension.
The FDA said Arcan Bitters is registered with the Authority as a food product and, as such, must not contain any drug substance.
It warned that the presence of Sildenafil Citrate in the alcoholic beverage poses serious health and safety risks to consumers.
The Authority explained that Sildenafil Citrate can interact with other medicines and cause a sudden drop in blood pressure, potentially resulting in serious complications such as stroke and heart attack.
It further warned that the substance could cause long-term health complications, including loss of vision and hearing.
The FDA has therefore strongly advised the public to refrain from purchasing or consuming Arcan Bitters.
Retailers and distributors have also been directed to comply with the recall and report any persons found selling the product to the nearest FDA office.
The Authority said it will undertake the safe disposal of the recalled products.
It further warned Unni Associates Company Limited that failure to comply with the recall and other directives could attract additional regulatory sanctions, including criminal prosecution.
The FDA said the adulteration of food products constitutes an offence under Section 100(3) of the Public Health Act, 2012 (Act 851), which prohibits the manufacture, advertising or sale of adulterated products.
The law also prohibits the manufacture, labelling, packaging, sale or advertisement of food products in a manner that is false, misleading or deceptive regarding their character, nature, value, additives, quality, substance or composition.
The Authority urged consumers and businesses to cooperate with the recall to ensure the complete removal of Arcan Bitters from the market.
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