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    You are at:Home»Politics»FDA orders recall of Arcan Bitters over undeclared drug substance
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    FDA orders recall of Arcan Bitters over undeclared drug substance

    Papa LincBy Papa LincSeptember 3, 2026No Comments2 Mins Read1 Views
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    FDA orders recall of Arcan Bitters over undeclared drug substance
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    The Food and Drugs Authority (FDA) has ordered the recall of Arcan Bitters from the market after laboratory tests found that the product had been adulterated with Sildenafil Citrate.

    The Authority has directed Unni Associates Company Limited, the manufacturer of the product, to recall all Arcan Bitters from the market within 14 days.

    The FDA announced the closure of the company’s factory at Parkoso in the Asokore Mampong Municipality of the Ashanti Region, where the product is manufactured.

    According to a public release issued by the Authority on September 2, 2026, the action followed laboratory analysis conducted on Arcan Bitters, which contains 35 per cent alcohol by volume.

    The analysis established the presence of Sildenafil Citrate, a prescription-only medicine used to treat erectile dysfunction in men and pulmonary arterial hypertension.

    The FDA noted that Arcan Bitters is registered as a food product and alcoholic drink and, therefore, must not contain any drug substance.

    It explained that the presence of Sildenafil Citrate in the product poses serious health and safety risks to consumers.

    According to the Authority, the drug can interact with other medicines and cause a sudden drop in blood pressure, which could lead to stroke or heart attack.

    It added that the substance may also cause long-term health problems, including loss of vision and hearing.

    The FDA stated that adulterating food products is an offence under the Public Health Act, 2012 (Act 851).

    It warned Unni Associates Company Limited that failure to comply with its directives could result in further regulatory sanctions, including criminal prosecution.

    The Authority will also supervise the safe disposal of all recalled products.

    The FDA has advised the public to refrain from purchasing or consuming Arcan Bitters and urged retailers and distributors to comply with the recall directive.

    It further encouraged the public to report persons who continue to offer the product for sale to the nearest FDA office to ensure its complete removal from the market.

    By: Jacob Aggrey



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