The Food and Drugs Authority (FDA) has revoked the marketing authorisation of Omama Herbal Mixture after laboratory analyses confirmed that the product had been adulterated with prescription-only medicines, posing serious risks to public health.
In a statement signed by the Acting Chief Executive Officer, Professor Kwabena Frimpong-Manso Opuni, the Authority said the move followed a market surveillance exercise conducted in collaboration with the Ghana Police Service.
FDA Laboratory Tests Reveal Dangerous Substances
According to the FDA, tests revealed that Omama Herbal Mixture contained Diazepam, Metronidazole, Paracetamol, and Niacinamide — all allopathic drugs that are not permitted in registered herbal products.
The herbal mixture was originally registered only as a remedy for malaria and loss of appetite, but the addition of these pharmaceutical substances makes it unsafe for consumption.
“The medicines found in Omama Herbal Mixture are dangerous when taken without prescription or advice from a qualified health professional,” the FDA cautioned in its statement.
Public Safety and Product Recall
The FDA has urged the public to immediately stop purchasing or using the product, citing potential health hazards from the unapproved ingredients.
The Authority also disclosed that it was working closely with Omama Herbal Group Limited to recall all affected batches from the market for safe disposal.
Additionally, both regulatory and criminal actions have been initiated against the individuals responsible for the adulteration.
“The FDA will not relent in its effort to ensure public health and safety,” the statement emphasized.
Health Risks Associated with the Adulterated Substances
The inclusion of the detected pharmaceutical ingredients in a herbal mixture can lead to serious medical complications:
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Diazepam – a controlled drug used for anxiety and sleep disorders; may cause drowsiness, addiction, or respiratory issues if taken unsupervised.
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Metronidazole – an antibiotic; improper use can lead to resistance or severe side effects.
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Paracetamol – excessive intake can cause liver damage.
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Niacinamide – though a vitamin, high doses may cause skin flushing or gastrointestinal distress.
The FDA warned that the combination of these substances without medical supervision could be life-threatening.
FDA’s Commitment to Consumer Protection
This latest action forms part of the FDA’s ongoing efforts to regulate the herbal medicine industry and protect consumers from unsafe and unapproved products.
The Authority reaffirmed that market surveillance and product testing would continue nationwide to detect and remove any adulterated products from circulation.
“We are committed to protecting public health and ensuring that only safe and effective products remain on the market,” Prof. Opuni stated.
FAQs About the Omama Herbal Mixture Recall
1. Why did the FDA revoke Omama Herbal Mixture’s authorisation?
Because laboratory tests found prescription-only medicines in the product, violating regulations for herbal remedies.
2. What should consumers do if they have purchased Omama Herbal Mixture?
Stop using it immediately and return it to the nearest FDA office or approved collection centre.
3. What are the possible health effects of consuming the adulterated product?
Users may experience drowsiness, liver damage, antibiotic resistance, or allergic reactions due to the unapproved substances.
