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.
FDA also closed down the company’s manufacturing facility at Jacobu in the Ashanti Region and warned that failure to comply with the directives could attract further regulatory sanctions, including criminal prosecution.
In a statement, the FDA said it would oversee the safe disposal of all recalled products to ensure their complete removal from circulation and protect public health.
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The regulatory action follows laboratory analysis of Franko Herbal Mixture, which is registered with the Authority as a herbal medicinal product containing Carica papaya, Alstonei boonei and Tetrapleura tetraptera.
However, the analysis established that the product had been adulterated with diazepam, a prescription-only medicine, and paracetamol, a medication commonly used to relieve pain and reduce fever.
The FDA said the presence of the two pharmaceutical substances in a product registered strictly as a herbal medicine violated regulatory requirements and posed serious health and safety risks to consumers.
The FDA explained that diazepam belongs to a class of medicines known as benzodiazepines and is prescribed for conditions including anxiety disorders, acute alcohol withdrawal, muscle spasms and certain types of seizures.
While the medicine has legitimate medical uses, the FDA warned that its presence in an unapproved herbal formulation could expose consumers to potentially dangerous effects, particularly when taken alongside other medications.
The Authority said diazepam can interact with other medicines and increase the risk of severe sedation, respiratory depression, coma and death.
FDA also cautioned that prolonged use or abuse of the drug could interfere with the functioning of the central nervous system.
Possible effects include confusion, forgetfulness, dizziness, fatigue, nightmares, hallucinations, impaired judgement and seizures.
The Authority also raised concerns about the presence of paracetamol in the mixture, explaining that although the medicine is commonly used for the temporary relief of mild-to-moderate pain and fever, excessive intake can have serious consequences.
It said the risks associated with the two substances reinforced the need for consumers to avoid the product while the recall and enforcement measures were being implemented.
CNR