FDA orders recall of Arcan Bitters over undeclared drug substance
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 […]
The Food and Drugs Authority (FDA) in Ghana has mandated Unni Associates Company Limited to recall Arcan Bitters from the Ghanaian market within 14 days, following laboratory analysis that detected Sildenafil Citrate, a prescription drug, in the alcoholic beverage. The FDA has also suspended the company's manufacturing operations at Parkoso in the Ashanti Region.
Sildenafil Citrate, used to treat erectile dysfunction and pulmonary arterial hypertension, can cause dangerous blood pressure drops and long-term health issues, including vision and hearing loss. The FDA warned that Arcan Bitters, registered as a food product, must not contain any drug substances, and consuming it poses serious health risks.
Retailers and distributors must comply with the recall, and any selling the product should be reported to the nearest FDA office. The FDA will handle the safe disposal of the products, and Unni Associates Company Limited faces potential criminal prosecution for violating the Public Health Act. Consumers and businesses are urged to cooperate with the recall to remove Arcan Bitters from the market.
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