The Food and Drugs Authority (FDA) has uncovered an organised operation producing and distributing falsified Dr Alfred Capsules, with laboratory tests confirming the products had been adulterated with sildenafil citrate.
The dietary supplement, which is marketed for male vitality, has been circulating on social media platforms despite not being registered with the FDA.
The Authority said its investigations led to enforcement operations in Accra and Suhum, where it identified a syndicate allegedly responsible for manufacturing and distributing the falsified capsules to different parts of the country.
“Following regulatory intelligence and subsequent enforcement operations, the FDA has identified an organised syndicate operating in Accra and Suhum who manufacture and distributes the falsified products across the country,” the statement said.
Two people suspected of being connected to the operation have been arrested and are currently assisting the authorities with investigations.
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“Two suspects linked to this illicit activity are currently on police enquiry bail, assisting with ongoing investigations,” it said.
The FDA’s Centre for Laboratory Services and Research (CLSR) found sildenafil citrate in the falsified capsules.
The substance was not declared as part of the product’s formulation.
“Additionally, laboratory analysis by the FDA Centre for Laboratory Services and Research (CLSR) confirmed that these falsified variants of the Dr Alfred Capsules have been adulterated with Sildenafil citrate, which is an allopathic drug substance,” the FDA said.
Sildenafil citrate is a phosphodiesterase type 5 (PDE5) inhibitor commonly used as a prescription medicine to treat erectile dysfunction in men and pulmonary arterial hypertension.
The FDA stressed that the substance is not contained in the genuine Dr Alfred Capsules registered for sale in Ghana.
The legitimate product is manufactured by CV Al Manar Herbafit in Yogyakarta, Indonesia, and registered in Ghana by Unateus Ghana Limited as a food supplement.
“The registered product DOES NOT contain Sildenafil citrate,” the FDA stated.
The Authority said consumers can distinguish the genuine product from the falsified versions by examining the packaging, batch information, seals and capsules.
Genuine Dr Alfred Capsules are sold in a 30-capsule pack and come in high-quality containers with clear printing, proper text alignment and a secure finish.
The counterfeit versions have been found in both 30- and 60-capsule packs and generally feature inferior packaging, poor-quality printing and blurred or altered lettering.
There are also discrepancies in the batch numbers.
According to the FDA, legitimate products carry traceable batch numbers that correspond on the product label and the base of the container. The falsified products, however, have mismatched batch numbers and fictitious FDA registration numbers.
The security features provide another distinction.
Authentic products have a uniform, intact tamper-evident seal associated with the marketing authorisation holder on the bottle cap, as well as an aluminium inner seal that becomes visible when the bottle is opened.
The falsified versions lack the safety seals on their bottle caps and may or may not contain an aluminium inner seal.
The capsules themselves also differ.
The genuine capsules have a consistent wine-red shell containing fine, uniform off-white powder.
The falsified products have appeared in different colours, including transparent and black-and-red capsules, with greenish-brown powder inside.
The FDA has urged consumers to exercise caution when buying medicines, herbal products and dietary supplements, particularly through social media and other unverified online platforms.
“The public is advised to desist from purchasing medications, herbal remedies, or dietary supplements from unverified online networks and social media handles,” the Authority said.
The FDA has also instructed pharmacies, herbal shops and distributors to examine their inventories for the affected products and report any suspected cases.
“All pharmacies, herbal shops and distributors are directed to immediately inspect their stock and report any suspicion of falsified products to the FDA,” it said.
Consumers who already have the falsified Dr Alfred Capsules have been directed to surrender them to the nearest FDA regional office.
“Anyone in possession of these falsified products must immediately return them to the nearest FDA regional office across the country,” the statement said.
The FDA said the products were manufactured in unauthorised, unregulated and unhygienic conditions, raising serious concerns over the potential health risks to consumers.
