FDA orders recall of Franko Herbal Mixture over undeclared pharmaceutical ingredients

Story by: Regina Bless

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 result in further regulatory sanctions, including criminal prosecution.

In a statement, the FDA said it would supervise the safe disposal of all recalled products to ensure they are completely removed from circulation and to protect public health.

The action follows laboratory analysis of the mixture, which was registered as a herbal medicinal product containing Carica papaya, Alstonia boonei and Tetrapleura tetraptera.

However, the tests revealed that the product had been adulterated with diazepam, a prescription-only medicine, and paracetamol, which is commonly used to relieve pain and reduce fever.

According to the FDA, the presence of these pharmaceutical substances in a product registered strictly as herbal medicine violates regulatory requirements and poses potential health risks to consumers.

The Authority explained that diazepam is used to treat conditions such as anxiety, muscle spasms, acute alcohol withdrawal and certain types of seizures. However, when taken without proper medical supervision, it can cause serious complications.

The FDA warned that diazepam can interact with other medicines and may lead to excessive sedation, breathing difficulties, coma and even death. Prolonged use or misuse can also affect the central nervous system, potentially causing dizziness, confusion, memory problems, impaired judgement and other adverse effects.

The Authority also raised concerns about the presence of paracetamol in the mixture. Although the medicine is widely used to manage pain and fever, taking excessive amounts can cause severe liver damage.

The FDA has therefore urged consumers to avoid using Franko Herbal Mixture while the recall and enforcement measures are being implemented.

The development highlights the importance of regulatory oversight in ensuring that medicinal products meet approved safety and quality standards. It also serves as a reminder to consumers to purchase medicines from reliable sources and consult qualified healthcare professionals before using herbal preparations.

The FDA’s enforcement action is intended to prevent further exposure to the potentially harmful product and safeguard the health and safety of the public.