Accra:The Food and Drugs Authority (FDA) has mandated an immediate recall of the Franko Herbal Mixture by Franko Herbal Centre. The order comes after laboratory tests revealed dangerous adulteration in the product, prompting the regulatory body to demand its withdrawal from the market within fourteen days.
According to Ghana Web, the FDA's public notice, signed by the Chief Executive Officer, stated that the manufacturing facility located in Jacobu, Ashanti Region, has been shut down. Plans are underway for the safe disposal of all confiscated products.
The FDA has cautioned that the manufacturer might face severe regulatory actions, including the possibility of criminal prosecution, if the recall order is not strictly adhered to. While Franko Herbal Mixture was registered as an all-herbal preparation containing Carica papaya, Alstonia boonei, and Tetrapleura tetraptera, tests uncovered the illegal presence of active pharmaceutical ingredients such as Diazepam and Paracetamol.
The FDA highlighted that the adulteration of herbal products violates Section 111 of the Public Health Act, 2012 (Act 851). It is considered an offense to manufacture, label, package, sell, or advertise any herbal medicinal product in a misleading way regarding its composition and nature.
The regulator warned of the public health risks associated with consuming unapproved combinations of prescription medication. Specifically, Diazepam can interact with other medicines, increasing the risk of severe sedation, respiratory depression, coma, and death. Long-term misuse can affect the central nervous system, leading to confusion, dizziness, impaired judgment, and seizures.
Furthermore, undeclared doses of Paracetamol pose a risk of accidental overdoses, which could result in acute liver failure or fatality if untreated. The FDA has urged the public, distributors, and retailers to stop the purchase, sale, and consumption of Franko Herbal Mixture immediately. Any sightings of the product should be reported to the nearest FDA office to ensure its complete removal from the market.
Source Ghana Web