The Food and Drugs Authority (FDA) has shut down the manufacturing facility of Franko Herbal Centre at Jacobu in the Ashanti Region and ordered the company to withdraw its Franko Herbal Mixture from the market within 14 days after laboratory tests detected unapproved pharmaceutical substances in the product.
The Authority said the mixture, registered as a herbal medicinal product, contained diazepam, a prescription-only medicine, and paracetamol, which is commonly used to relieve pain and reduce fever.
The discovery has prompted regulatory action, with the FDA warning that failure to comply with the recall directive could result in additional sanctions, including criminal prosecution.
In a statement, the Authority said it would supervise the safe disposal of all recalled products to ensure they were completely removed from circulation and prevent further exposure of consumers to potential health risks.
The regulatory action followed laboratory analysis of the product, which was registered as containing three herbal ingredients: Carica papaya, Alstonei boonei and Tetrapleura tetraptera.
However, the analysis revealed the presence of the two pharmaceutical substances, which the FDA said should not have been included in a product registered strictly as a herbal medicine.
FDA warns of potential health risks
The Authority expressed concern that the presence of diazepam in the herbal formulation could expose unsuspecting consumers to serious health complications, particularly because they might not know they were taking a prescription medicine.
Diazepam belongs to a class of medicines known as benzodiazepines and is prescribed for conditions such as anxiety disorders, acute alcohol withdrawal, muscle spasms and certain types of seizures.
Although the medicine has recognised therapeutic uses, the FDA warned that taking it without appropriate medical supervision could be dangerous.
According to the Authority, diazepam can interact with other medicines and increase the risk of severe sedation, respiratory depression, coma and death.
Prolonged use or abuse of the drug could also affect the central nervous system, potentially causing confusion, forgetfulness, dizziness, fatigue, nightmares, hallucinations, impaired judgement and seizures.
The FDA said these risks were particularly concerning in a product marketed as herbal medicine, where consumers might not expect to be exposed to pharmaceutical substances.
Paracetamol contamination raises further concerns
The Authority also raised concerns about the detection of paracetamol in the mixture.
Although paracetamol is widely used for the temporary relief of mild-to-moderate pain and fever, excessive intake can cause serious health complications.
The FDA’s findings mean consumers taking the herbal mixture could unknowingly consume the pharmaceutical substances alongside other medicines containing the same ingredients, potentially increasing the risk of adverse effects.
The Authority has therefore urged consumers to avoid the product while the recall and enforcement measures are being implemented.
Company faces regulatory action
The closure of Franko Herbal Centre’s manufacturing facility and the 14-day recall deadline form part of the FDA’s response to the findings.
The Authority said it would monitor compliance with the directives and oversee the disposal of recalled products to ensure they did not return to the market.
It also warned that any failure to comply could attract further regulatory measures, including criminal prosecution.
The case highlights the importance of regulatory oversight in the herbal medicine industry and the need for manufacturers to ensure that products contain only approved ingredients consistent with their registration.
The FDA’s action is intended to protect consumers from undisclosed pharmaceutical substances and reinforce compliance with standards governing the manufacture and sale of herbal medicinal products in Ghana.
