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 found it contained an undeclared pharmaceutical substance.
The FDA said the alcoholic drink, manufactured at Parkoso in the Asokore Mampong Municipality of the Ashanti Region, had been adulterated with Sildenafil Citrate, a phosphodiesterase type 5 (PDE5) inhibitor.
Sildenafil Citrate is a prescription medicine commonly used to treat erectile dysfunction in men and pulmonary arterial hypertension.
Following the findings, the FDA has also ordered the closure of the factory where Arcan Bitters is manufactured. It said it would oversee the safe disposal of all recalled products.
The Authority warned Unni Associates Company Limited that failure to comply with the recall directive could attract further regulatory sanctions, including criminal prosecution.
According to the FDA, Arcan Bitters is registered as a food product—specifically an alcoholic drink—and therefore must not contain any drug substance.
“The presence of Sildenafil Citrate in a food product poses serious health and safety risks to the public,” the FDA said.
The Authority explained that Sildenafil Citrate could 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 said the manufacture, advertising or sale of adulterated products is prohibited under Section 100(3) of the Public Health Act, 2012 (Act 851). It also said the law prohibits the manufacture, labelling, packaging, sale or advertisement of food products in a manner that is false, misleading or deceptive regarding their character, nature, additives, quality, substance or composition.
The Authority has consequently urged consumers to refrain from purchasing or consuming Arcan Bitters.
Retailers and distributors have also been directed to remove the product from their outlets and report anyone offering it for sale to the nearest FDA office to facilitate its complete withdrawal from the market.
The FDA urged the public to report activities that could compromise public health and safety through its phone/WhatsApp lines 0551112224/5 or by email at fda@fda.gov.gh.
