FDA revokes marketing authorisation for Omama Herbal Mixture.
FDA revokes marketing authorisation for Omama Herbal Mixture.
The Food and Drugs Authority (FDA) has revoked the marketing authorization of Omama Herbal Mixture after laboratory analysis revealed that the product had been adulterated with several prescription-only drugs.
In a statement released on Friday, the FDA stated that its market surveillance, conducted in collaboration with the Ghana Police Service, showed that Omama Herbal Mixture contained Diazepam, Metronidazole, Paracetamol, and Niacinamide, all allopathic medicines.
According to the Authority, the herbal mixture was registered as a herbal medicinal product indicated for the treatment of malaria and loss of appetite.
It therefore should not contain any synthetic or prescription medications.
“The medicines found in Omama Herbal Mixture are dangerous when taken without prescription and/or advice from a qualified health professional,” the FDA warned.
The Authority has advised the public to stop patronizing the product immediately, as its consumption poses serious health risks.
Meanwhile, the FDA says it is working with Omama Herbal Group Limited to recall all affected products from the market for safe disposal, adding that appropriate regulatory actions, including criminal prosecution, will be initiated.
The statement assured the public of the FDA’s continued commitment to protecting public health and safety.
“The FDA wishes to assure the public that it will not relent in its effort to ensure public health and safety,” the statement concluded.
The Authority also urged the public to report anyone found selling Omama Herbal Mixture to the nearest FDA office.
