FDA shuts Franko Herbal Centre factory, recalls mixture over drug adulteration

The Food and Drugs Authority (FDA) has ordered the recall of Franko Herbal Mixture from the Ghanaian market after laboratory tests found that the product contained diazepam and paracetamol, which were not declared as ingredients.

The authority has also shut down the manufacturing factory operated by Franko Herbal Centre at Jacobu in the Ashanti Region and given the company 14 days to recall the product.

The FDA cautioned that the company could face further regulatory sanctions, including criminal prosecution, if it fails to comply with the directive.

In a product recall notice dated October 19, the authority said laboratory analysis established that the herbal mixture, registered to contain plant ingredients, had been adulterated with the two pharmaceutical substances.

The product was registered to contain Carica papaya, Alstonia boonei and Tetrapleura tetraptera, but the tests detected diazepam, a prescription-only medicine, and paracetamol, an over-the-counter painkiller.

“The presence of Diazepam and Paracetamol in herbal medicinal product poses serious health and safety risks to the public,” the FDA said in part of the notice.

Diazepam is used to treat conditions including anxiety disorders, muscle spasms and certain types of seizures.

However, the FDA said it can interact with other medicines and increase the risk of severe sedation, breathing difficulties, coma and death.

The authority also cautioned that prolonged use or abuse of diazepam could affect the central nervous system, causing confusion, memory problems, dizziness, fatigue, hallucinations and impaired judgement.

Paracetamol is used to relieve pain and fever, but an overdose can cause severe liver damage and acute liver failure, which can be fatal if not treated promptly.

The FDA said the adulteration of herbal medicinal products violates Section 111 of the Public Health Act, 2012 (Act 851), which prohibits the sale of adulterated herbal medicines.

“The public is therefore strongly advised to refrain from purchasing and consuming Franko Herbal Mixture,” the authority stated.