FDA Orders Franko Herbal Mixture Off The Market Over Drug Contamination

The Food and Drugs Authority (FDA) has ordered Franko Herbal Centre to remove 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 over the contamination.

In a statement, the FDA said the product, which contains herbal ingredients including Carica papaya, Alstonia boonei and Tetrapleura tetraptera, was found to contain the two pharmaceutical substances.

As part of measures to address the issue, the FDA directed the company to withdraw the product from the market and announced the closure of its manufacturing facility.

“The FDA has ordered Franko Herbal Centre to recall its Franko Herbal Mixture from the market within fourteen (14) days. In addition, the manufacturing factory in the Ashanti Region has been closed down,” the statement said.

The Authority warned that the presence of the substances in a herbal product could pose serious health risks to consumers.

According to the FDA, diazepam can cause severe drowsiness and breathing difficulties, and in serious cases, coma or death. It may also lead to confusion, dizziness, fatigue, hallucinations and impaired judgement.

Paracetamol, on the other hand, can cause severe liver damage and acute liver failure when taken in excessive amounts.

The FDA noted that the sale of adulterated herbal medicinal products containing other drug substances is prohibited under Section 111 of the Public Health Act, 2012 (Act 851).

It further warned that the company could face additional regulatory action if it fails to comply with the directive.

“The FDA will conduct a safe disposal of the recalled products, and has warned the company that it risks further regulatory sanctions, including criminal prosecution, if it fails to abide by the directives,” the statement said.

The Authority has urged the public to stop purchasing or consuming the product and called on retailers and distributors to ensure it is removed from sale.

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

Consumers who come across the product being sold have been advised to report it to the nearest FDA office.