FDA recalls Arcan Bitters over undeclared erectile dysfunction drug

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The Food and Drugs Authority (FDA) has ordered the recall of Arcan Bitters from the Ghanaian market after laboratory tests found the alcoholic drink had been adulterated with Sildenafil Citrate, a prescription-only drug used to treat erectile dysfunction.

The FDA has given the manufacturer, Unni Associates Company Limited, 14 days to withdraw the product from the market.

The company’s manufacturing facility at Parkoso in the Asokore Mampong Municipality of the Ashanti Region has also been shut down.

In a public notice issued on Wednesday, September 2, the FDA said laboratory analysis of Arcan Bitters, labelled as containing 35% alcohol by volume, established the presence of Sildenafil Citrate.

Sildenafil Citrate is a Phosphodiesterase Type 5 (PDE5) inhibitor and is not permitted in food products.

The FDA said Arcan Bitters is registered with the Authority as an alcoholic beverage and must therefore not contain any drug substance.

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