The Food and Drugs Authority (FDA) has ordered Franko Herbal Centre to recall its Franko Herbal Mixture from the market within 14 days after laboratory analysis detected the presence of diazepam and paracetamol in the product.
The Authority has also shut down the company’s manufacturing factory at Jacobu in the Ashanti Region and warned that failure to comply with the directives could result in further regulatory sanctions, including criminal prosecution.
In a regulatory notice, the FDA said laboratory analysis established that the herbal mixture, registered as containing plant materials, had been adulterated with pharmaceutical substances.
The product was registered to contain Carica papaya, Alstonia boonei and Tetrapleura tetraptera, according to the Authority.
However, the laboratory findings identified diazepam, a prescription-only medicine, and paracetamol, a commonly used painkiller and fever reducer, in the mixture.
The FDA said the product was registered as a herbal medicinal product and, therefore, “must not contain any other drug substance.”
The Authority has raised concerns about the potential health consequences of consuming the adulterated mixture, particularly because the pharmaceutical substances were present in a product marketed as herbal medicine.
According to the FDA, diazepam belongs to a class of medicines known as benzodiazepines and is used to treat conditions including anxiety disorders, acute alcohol withdrawal, muscle spasms and certain types of seizures.
The Authority warned that diazepam can interact with other medicines, increasing the risk of “severe sedation, respiratory depression, coma, and death.”
It also cautioned that prolonged use or abuse of the medicine may affect the central nervous system, causing confusion, forgetfulness, dizziness, fatigue, nightmares, hallucinations, impaired judgment and seizures.
Paracetamol, meanwhile, is used for the temporary relief of mild-to-moderate pain and fever. The FDA warned that an overdose could cause severe liver damage and acute liver failure, which may be fatal without prompt treatment.
In view of these risks, the Authority has strongly advised the public to stop purchasing and consuming Franko Herbal Mixture.
The regulator said the adulteration of herbal medicinal products constitutes an offence under Section 111 of the Public Health Act, 2012 (Act 851).
The law prohibits the sale of adulterated herbal medicinal products. It also prohibits the manufacture, labelling, packaging, sale or advertisement of such products in ways that are false, misleading or deceptive regarding their character, nature, value, additives, quality, substance or composition.
The FDA said Franko Herbal Mixture violated these requirements because its registration as a herbal medicinal product did not permit the inclusion of other drug substances.
The FDA said it would oversee the safe disposal of the recalled products as part of measures to remove the mixture from circulation.
It has also directed retailers and distributors to comply with the recall and urged members of the public to report anyone continuing to sell the product to the nearest FDA office.
The Authority’s directive is intended to ensure the complete removal of Franko Herbal Mixture from the market and protect consumers from the potential dangers associated with the undisclosed pharmaceutical ingredients.
The FDA warned that the company could face additional regulatory action, including criminal prosecution, if it fails to comply with the recall and other directives.
Read the statement below:
