BY GRACE ZIGAH
The Food and Drugs Authority (FDA) in the Ashanti Region has shut down a second production facility belonging to Unni Associates Company Limited, manufacturers of Arcan Bitters, after the company allegedly defied an earlier closure order and resumed production at a different location.
The latest enforcement action, carried out at Senfi in the Bekwai Municipality, comes amid an ongoing investigation into the discovery of Sildenafil Citrate, a prescription medicine, in the alcoholic beverage.
The development has raised fresh concerns about regulatory compliance and consumer safety, with the FDA accusing the company of continuing its operations without the Authority’s knowledge after its initial factory was closed in September.
The first facility, located at Parkoso in the Asokore Mampong Municipality, was shut down following laboratory tests that detected the undeclared medicinal substance in Arcan Bitters. The FDA subsequently ordered a recall of the product from the Ghanaian market.
However, according to the Authority, the company relocated its operations to Senfi and continued manufacturing the beverage, prompting officials to move in and close the second facility.
FDA Discovers Prescription Drug in Alcoholic Beverage
The FDA’s enforcement action follows laboratory analysis that established the presence of Sildenafil Citrate in Arcan Bitters, a product registered as an alcoholic beverage.
Sildenafil Citrate is a prescription medicine used to treat erectile dysfunction and pulmonary arterial hypertension. Its presence in a beverage without declaration or authorisation has raised concerns about the potential health risks to consumers who may unknowingly ingest the substance.
The Ashanti Regional Head of the FDA, Dr Ashraf Haruna, said the discovery was particularly concerning because Arcan Bitters, which contains 35 per cent alcohol, was not authorised to contain medicinal substances.
He explained that the product was registered as an alcoholic food product and was therefore not permitted to contain undeclared pharmaceutical ingredients.
Sildenafil Citrate belongs to a class of medicines known as phosphodiesterase type 5 (PDE5) inhibitors. The FDA’s concern centres on the presence of the prescription drug in an alcoholic beverage marketed for consumption without consumers necessarily knowing that it contains the substance.
The recall order was intended to remove the affected product from the market and prevent further exposure while regulatory concerns were being addressed.
Second Factory Closed After Alleged Relocation
The latest shutdown has intensified the FDA’s enforcement efforts against Unni Associates Company Limited.
According to the Authority, the company continued production after its Parkoso facility was closed, relocating its operations to Senfi without informing the regulator.
FDA officials subsequently moved to the new location, locked the facility and posted caution notices at its entrances.
During the operation, officers secured 23 barrels of alcoholic content intended for production, approximately 1,500 boxes of Arcan Bitters, more than 5,000 empty bottles and other manufacturing materials.
The quantities of finished products and production materials found at the facility have added to concerns about the scale of the company’s operations following the initial closure.
The FDA has not indicated in the supplied report whether the materials secured at the Senfi facility have undergone further laboratory testing or whether additional products have been recalled beyond the earlier directive.
Factory Owner Faces Possible Arrest
Dr Haruna disclosed that the FDA was working with the police to facilitate the arrest of the factory owner.
The move signals a possible escalation of the regulatory action as authorities investigate the alleged resumption of production and the circumstances surrounding the manufacture of the beverage containing the undeclared prescription medicine.
The FDA’s position is that manufacturers must comply with product registration requirements and regulatory directives designed to protect public health.
The alleged relocation and continuation of production after the first closure have become a central issue in the latest enforcement action.
However, the allegations against the company and its owner remain subject to the appropriate investigative and legal processes.
Public Warned Against Consuming Arcan Bitters
The FDA has urged consumers to refrain from purchasing or consuming Arcan Bitters in response to the findings.
Retailers, distributors and other operators within the beverage supply chain have also been asked to cooperate with efforts to remove the product from circulation.
