Ghana FDA Revokes Marketing Authorization for Omama Herbal Mixture Due to Adulteration

The Food and Drugs Authority (FDA) of Ghana has revoked the marketing authorization for Omama Herbal Mixture after laboratory tests confirmed the product was illegally adulterated with prescription-only medicines.

The decision follows a market surveillance exercise conducted in collaboration with the Ghana Police Service, revealing the presence of Diazepam, Metronidazole, Paracetamol, and Niacinamide within the herbal mixture. These allopathic drugs are not permitted in registered herbal preparations, according to the FDA. Omama Herbal Mixture was originally registered as a remedy for malaria and loss of appetite, and the inclusion of these unauthorized substances poses significant health risks to consumers who may be unaware they are ingesting powerful pharmaceuticals.

“The medicines found in Omama Herbal Mixture are dangerous when taken without prescription or advice from a qualified health professional,” the FDA cautioned in a statement. The Authority is urging the public to immediately cease purchasing or using the product and is working with Omama Herbal Group Limited to recall all affected batches for safe disposal. Consumers concerned about potential adverse effects should consult a healthcare provider; more information on drug safety can be found at the World Health Organization.

Regulatory and criminal actions have been initiated against those responsible for the adulteration, demonstrating the FDA’s commitment to public health and safety. The FDA has requested that anyone encountering Omama Herbal Mixture for sale report it to the nearest FDA office, and continues to monitor the market for similar issues, as detailed in their official website. The FDA stressed that it “will not relent in its effort to ensure public health and safety.”