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The Food and Drugs Authority (FDA) has ordered Unni Associates Company Limited to recall Arcan Bitters from the market within 14 days after laboratory tests detected undeclared sildenafil citrate in the alcoholic beverage.
In a statement signed by the Chief Executive Officer of the FDA, the company’s manufacturing facility at Parkoso in the Asokore Mampong Municipality of the Ashanti Region has also been closed down, with the FDA set to oversee the safe disposal of the recalled products.
The FDA cautioned the company that “it risks further regulatory sanctions, including criminal prosecution, if it fail to abide by the directives.”
According to the Authority, Sildenafil Citrate is a prescription medicine used to treat erectile dysfunction and pulmonary arterial hypertension, warning that “its presence in a food product could pose serious health risks, including dangerous interactions with other medicines that may cause a sudden drop in blood pressure, stroke, or heart attack.”
FDA urged the public, retailers and distributors to refrain from purchasing, selling or consuming Arcan Bitters and to report any outlets still offering the product for sale to their nearest office.
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