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 undeclared pharmaceutical substances in the product. The Authority has also shut down the company’s manufacturing factory at Jacobu in the Ashanti Region.
The FDA disclosed that the tests identified diazepam and paracetamol in the herbal mixture, raising concerns about the product’s safety and compliance with regulatory requirements.
According to the Authority, the product was registered as a herbal medicinal preparation containing three plant ingredients: Carica papaya, Alstonia boonei and Tetrapleura tetraptera. However, laboratory analysis established that the mixture had been adulterated with pharmaceutical drugs.
“The analysis established that Franko Herbal Mixture, which was registered to contain herbal plants, namely Carica papaya, Alstonia boonei and Tetrapleura tetraptera, has been adulterated with the underlisted pharmaceutical products,”
Food and Drugs Authority (FDA)
Diazepam is a prescription-only medicine belonging to the benzodiazepine class of drugs. It is used to treat anxiety disorders, acute alcohol withdrawal, muscle spasms and certain types of seizures. Paracetamol, on the other hand, is an over-the-counter medicine commonly used to relieve mild to moderate pain and reduce fever.
The FDA explained that the presence of these substances in a product registered exclusively as a herbal medicine contravenes the requirements governing the manufacture and sale of herbal medicinal products.
The Authority further noted that adulterating a herbal medicinal product constitutes an offence under Section 111 of the Public Health Act, 2012 (Act 851), which prohibits the sale of adulterated herbal medicines.
The law also prohibits the manufacture, labelling, packaging, sale or advertisement of herbal medicinal products in ways that are false, misleading or deceptive regarding their character, nature, value, additives, quality, substance or composition.
According to the FDA, Franko Herbal Mixture violates these requirements because its registration as a herbal medicinal product does not permit the inclusion of undeclared pharmaceutical substances.
The Authority has consequently directed the company to withdraw all stocks of the product from the market within 14 days and warned that failure to comply could result in further regulatory sanctions, including criminal prosecution.
Health Risks to the Public
The FDA mentioned that the presence of diazepam and paracetamol in a herbal product poses serious health and safety risks.
Diazepam can interact with other medicines. Misuse or abuse of the drug can interfere with the functions of the central nervous system. The Authority listed confusion, forgetfulness, dizziness, fatigue, nightmares or hallucinations, impaired judgment and seizures among the possible symptoms.
An overdose of paracetamol, on the other hand, can cause severe liver damage and acute liver failure. The Authority warned that this can be fatal if not treated quickly.
“The presence of Diazepam and Paracetamol in herbal medicinal product poses serious health and safety risks to the public.”
Food and Drugs Authority (FDA)
Consumers of herbal products have no way of knowing that a bottle contains undeclared drugs. A person taking the mixture for a minor ailment could be taking diazepam without knowing it or could take paracetamol on top of other medicines containing it.
Advice to the Public, Retailers and Distributors
The FDA gave Franko Herbal Centre 14 days to withdraw all stock of Franko Herbal Mixture from the market. The factory in the Ashanti Region has been shut down.
The Authority will carry out the safe disposal of the recalled products. It warned the company of further regulatory sanctions, including criminal prosecution, if it does not abide by the directives.
The FDA strongly advised the public not to buy or consume Franko Herbal Mixture.
It also urged retailers and distributors to comply strictly with the recall directive. Anyone offering the product for sale should be reported to the nearest FDA office, so that the product can be completely removed from circulation.
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