The Food and Drugs Authority (FDA) Ghana has directed Unni Associates Company Limited to withdraw its Arcan Bitters product from the Ghanaian market within 14 days after laboratory tests detected an undeclared pharmaceutical substance in the alcoholic drink.
As part of the regulatory action, the FDA has shut down the manufacturing facility located at Parkoso in the Asokore Mampong Municipality of the Ashanti Region, where Arcan Bitters was produced.
The FDA has also announced plans to oversee the safe disposal of all recalled Arcan Bitters products and warned the company that failure to comply with the directive could result in additional regulatory measures, including criminal prosecution.
FDA Laboratory Test Detects Sildenafil Citrate
The action follows laboratory analysis conducted on Arcan Bitters (35% Alc/Vol) manufactured by Unni Associates Company Limited.
According to the FDA, testing confirmed that the alcoholic beverage 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. The FDA said the substance was not declared as an ingredient in Arcan Bitters.
FDA Issues Public Health Warning
The FDA has emphasized that Arcan Bitters is registered as a food product and alcoholic beverage, meaning it must not contain undeclared pharmaceutical or drug substances.
The presence of Sildenafil Citrate in an alcoholic drink has raised serious public health and food safety concerns, particularly because consumers may unknowingly take the drug while also using other prescription medicines.
The FDA warned that Sildenafil Citrate can interact with certain medications and potentially cause a dangerous drop in blood pressure. Such reactions may increase the risk of serious health complications, including stroke and heart attack.
The substance may also be associated with other adverse health effects, including potential vision and hearing problems, particularly with inappropriate or prolonged use.
FDA Advises Public to Stop Using Arcan Bitters
The Food and Drugs Authority Ghana has strongly advised consumers not to purchase or consume Arcan Bitters.
Retailers, wholesalers and distributors have also been instructed to comply with the recall and remove the affected product from circulation.
Members of the public who come across individuals or businesses offering Arcan Bitters for sale are encouraged to report them to the nearest FDA office to support the complete removal of the product from the Ghanaian market.
Adulterated Food Products Violate Ghanaian Law
The FDA said the regulatory action is consistent with provisions of the Public Health Act, 2012 (Act 851), which prohibits the manufacture, advertising or sale of adulterated products or products that fail to meet prescribed standards.
The law also prohibits the manufacture, labelling, packaging, sale or advertising of food products in ways that are false, misleading or deceptive regarding their character, nature, quality, composition, additives or other properties.
The FDA indicated that the presence of an undeclared drug substance in Arcan Bitters contravenes these requirements.
The Authority has therefore urged consumers and businesses to take the Arcan Bitters recall seriously and cooperate fully with the directive to protect public health and safety.
Source: newsthemegh.com