The Food and Drugs Authority (FDA) has ordered Unni Associates Company Limited to recall its Arcan Bitters product from the market within 14 days.
The factory in the Ashanti Region that manufactures the products has also been closed down.
The FDA in a statement issued on Wednesday said it will conduct a safe disposal of the recalled products, and warned the company that it risks further regulatory sanctions, including criminal prosecution, if it fails to abide by the directives.
The regulatory action follows laboratory analysis conducted on Arcan Bitters (35%Alc/Vol) manufactured by Unni Associates Company Limited at Parkoso, in the Asokore Mampong Municipality of the Ashanti Region.
The laboratory analysis according to the FDA established that Arcan Bitters has been adulterated with Sildenafil Citrate, a Phosphodiesterase Type 5 (PDE5) inhibitor, which is an undeclared drug substance in the product.
Sildenafil Citrate is a prescription only medicine used to treat erectile dysfunction in men as well as pulmonary arterial hypertension.
The adulteration of food products is an offence under Section 100 (3) of the Public Health Act, 2012 (Act 851), which prohibits the manufacture, advertising or offer for sale of any adulterated product, or a product that is different from the nature, substance and quality of the prescribed standard.
Similarly, it is an offense to manufacture, label, package, sell or advertise a food product in a manner that is false, misleading, or deceptive as regards its character, nature, value additives, quality, substance and composition. Arcan Bitters appears to have flouted all these requirements and more. Arcan Bitters is registered with the Authority as a Food Product (an alcoholic drink) and must not contain any drug substance. The presence of Sildenafil Citrate in a food product poses serious health and safety risks to the public. Sildenafil Citrate can interact with other medicines to cause sudden drop in blood pressure, which may lead to stroke and heart attack.
In addition to drug interactions, Sildenafil Citrate may cause long-term health problems, including loss of vision and hearing. The public is therefore strongly advised to refrain from purchasing and consuming this product. The Authority further advises the public, retailers and distributors to comply with this directive and report persons offering Arcan Bitters for sale to the nearest FDA offices to ensure complete removal of the product from trade. To report to the FDA any unhygienic practices or other activities that may compromise public health and safety, the contacts below will help.
