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 tests detected diazepam and paracetamol in the product.
The Authority has also shut down the company’s manufacturing facility at Jacobu in the Ashanti Region, warning that failure to comply with the directives could lead to further regulatory sanctions, including criminal prosecution.
In a statement, the FDA said laboratory analysis found that the product, registered as a herbal medicinal preparation containing Carica papaya, Alstonei boonei and Tetrapleura tetraptera, had been adulterated with diazepam, a prescription-only medicine, and paracetamol, 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 risks to consumers. It added that it would supervise the safe disposal of all recalled products to ensure they were completely removed from circulation.
The Authority explained that diazepam, a benzodiazepine, is prescribed for conditions including anxiety disorders, acute alcohol withdrawal, muscle spasms and certain types of seizures.
However, it warned that its presence in an unapproved herbal formulation could expose consumers to dangerous effects, particularly when taken with other medicines.
According to the FDA, interactions involving diazepam can increase the risk of severe sedation, respiratory depression, coma and death.
The Authority has urged compliance with its recall directive to protect public health and ensure the safety of medicinal products on the Ghanaian market.
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