FDA revokes authorisation of Omama Herbal Mixture after detecting prescription drugs
The Food and Drugs Authority (FDA) has withdrawn the marketing authorisation of Omama Herbal Mixture after laboratory investigations revealed that the product contained prescription-only medicines.
In a statement signed by the Acting Chief Executive Officer, Professor Kwabena Frimpong-Manso Opuni, the Authority said the decision followed a market surveillance exercise conducted in collaboration with the Ghana Police Service.
The FDA explained that tests confirmed the presence of Diazepam, Metronidazole, Paracetamol, and Niacinamide in the herbal product—ingredients that are not permitted in any registered herbal medicine in Ghana.
Omama Herbal Mixture, which was registered as a herbal remedy for malaria and loss of appetite, was found to be adulterated with the above substances, posing serious health risks to consumers.
“The medicines found in Omama Herbal Mixture are dangerous when taken without prescription or advice from a qualified health professional,” the Authority warned.
The FDA has therefore advised the public to stop purchasing or using the product immediately. It added that the Authority is working with Omama Herbal Group Limited to recall all affected batches from the market for safe disposal.
In addition, both regulatory and criminal actions have been initiated against those involved in the adulteration of the product.
The FDA reaffirmed its commitment to protecting public health and safety, urging the public to report any individuals, pharmacies, or medicine sellers who continue to stock Omama Herbal Mixture to the nearest FDA office.
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