The Food and Drugs Authority (FDA) has ordered the immediate recall of Arcan Bitters from the Ghanaian market after laboratory tests detected an undeclared pharmaceutical substance in the alcoholic beverage.
The directive has been issued to Unni Associates Company Limited, the manufacturer of the product, with the company given 14 days to withdraw Arcan Bitters from the market.
The FDA has also shut down the company’s manufacturing facility at Parkoso in the Asokore Mampong Municipality of the Ashanti Region following the laboratory findings.
According to the FDA, analysis conducted on Arcan Bitters established the presence of Sildenafil Citrate, a prescription medicine classified as a Phosphodiesterase Type 5 (PDE5) inhibitor.
Sildenafil Citrate is used medically in the treatment of erectile dysfunction and pulmonary arterial hypertension. The FDA said the substance was not declared in Arcan Bitters and should not be present in a product registered as a food or alcoholic beverage.
Arcan Bitters is registered with the FDA as an alcoholic food product and is labelled as containing 35 per cent alcohol by volume.
The regulator has expressed concern about the potential health risks associated with the presence of the undeclared drug in the beverage.
The FDA said Sildenafil Citrate can interact with certain other medicines and cause a significant drop in blood pressure. Such interactions, according to the Authority, could result in serious medical complications.
The Authority also warned that exposure to the substance could be associated with longer-term complications, including problems affecting vision and hearing.
The FDA has therefore advised members of the public not to purchase or consume Arcan Bitters.
Retailers and distributors have also been directed to remove the product from their shelves and other points of sale. Anyone found continuing to offer the affected product for sale is expected to be reported to the nearest FDA office.
The regulator said it will supervise the safe disposal of the recalled products to ensure they are removed from circulation.
The FDA further warned Unni Associates Company Limited that failure to comply with the recall and other directives could result in additional regulatory sanctions, including criminal prosecution.
The Authority said the adulteration of food products is prohibited under Section 100(3) of the Public Health Act, 2012 (Act 851). The law also prohibits the manufacture, labelling, packaging, sale or advertisement of food products in a manner that is false, misleading or deceptive regarding their nature, quality, composition or contents.
The FDA has consequently urged consumers and businesses to cooperate with the recall process as it works to ensure that Arcan Bitters is completely removed from the market.
The development comes as part of the regulator’s efforts to enforce safety standards for food and beverage products and protect consumers from products containing undeclared substances.
Source: Thepressradio.com
