The Food and Drugs Authority (FDA) has revoked the marketing authorization for the sale and distribution of six herbal medicinal products.
They are, Rockman Capsules manufactured by RockCare Clinic Limited; Mars for men imported by Joe D. Ventures and Tinatett Be4 Be4 Herbal Capsules manufactured by Tinattet Herbal Manufacturing and Marketing Co. Ltd.
The rest are, Angel Natural Capsules, manufactured by Angel Herbal Products Ltd.; Adom Gentleman Power Capsules manufactured by Dependable Pharmacy Ltd.; and Laud P Capsules manufactured by Stephen Gyan Herbal Centre.
A statement issued by the Authority said, the products were registered as herbal medicinal products indicated for male vitality but recent post-market surveillance activities conducted by the FDA revealed that the products have been adulterated with Vardenafil, a synthetic material used in the formulation of a prescription only medicine used for the treatment of erectile dysfunction.
“It is important to indicate that adverse effects of Vardenafil may have serious health implications which include,” the statement signed by the FDA's Chief Executive Mr Hudu Mogtari warned.
The statement said the component can lead to cerebrovascular haemorrhage (bleeding in the brain) which can lead to strokes; transient Ischaemic (heart) attack; palpitations and serious cardiovascular events including sudden cardiac death.
It can also cause priapism (sustained erection for long periods which can lead to impotence) as well as problems with kidney function, and problem with sight and hearing.
“The general public is therefore advised not to patronize the above listed herbal medicines. Meanwhile, the FDA is ensuring that the products are recalled from the market and the necessary regulatory actions applied”, the statement said.
It further maintained, “By this press release, all advertisements on the above-mentioned products must cease with immediate effect.”
Additionally, information from the general public on persons dealing in these products or suspected to be in any practice possible of endangering public health and safety with respect to FDA’s mandate is most welcome through any of the following contact numbers; 0244337235, 0267265087 or 0544863418.
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