The Food and Drugs Authority (FDA) has ordered Franko Herbal Centre to immediately withdraw its product, Franko Herbal Mixture, from the market within fourteen days following laboratory test results revealing dangerous adulteration.
In a public notice signed by the Chief Executive Officer, the regulatory body disclosed that the manufacturing factory located at Jacobu in the Ashanti Region has been shut down, with plans underway for the safe disposal of all confiscated products.
The regulator cautioned that the manufacturer faces further severe regulatory action, including potential criminal prosecution, should it fail to strictly comply with the recall order.
Although Franko Herbal Mixture was officially registered as an all-herbal preparation containing Carica papaya, Alstonia boonei, and Tetrapleura tetraptera, laboratory tests established that the product was illegally spiked with active pharmaceutical ingredients, namely Diazepam and Paracetamol.
Addressing the legal implications, the FDA emphasized that adulteration of herbal products directly contravenes Section 111 of the Public Health Act, 2012 (Act 851).
“It is an offense to manufacture, label, package, sell or advertise any herbal medicinal product in a manner that is false, misleading, or deceptive as regards its character, nature, value additives, quality, substance and composition,” the statement read, adding that the product violated its registered status as a purely herbal remedy.
Highlighting the public health hazards, the regulator warned that consuming unapproved combinations of prescription medication poses grave health risks.
“Diazepam can interact with other medicines which may increase the risk of severe sedation, respiratory depression, coma, and death,” the Authority noted, warning further that long-term misuse affects the central nervous system, triggering symptoms such as confusion, dizziness, impaired judgment, and seizures.
The FDA added that undeclared doses of Paracetamol could easily cause accidental overdoses leading to acute liver failure or fatality if left untreated.
Members of the general public, distributors, and retailers have been strongly advised to cease the purchase, sale, and consumption of Franko Herbal Mixture immediately and report anyone selling the product to the nearest FDA office to ensure its total removal from trade.
By: Rainbowradioonline.com/Ghana
