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The National Agency for Food and Drug Administration and Control (NAFDAC) has warned healthcare providers, patients and the general public about the circulation of falsified and parallel imported versions of Dostinex 0.5mg Tablets in Nigeria.
The agency disclosed this in a public alert published on its website on Monday.
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NAFDAC said Pfizer Nigeria Ltd, the Marketing Authorisation Holder (MAH) of the product, confirmed the presence of falsified and parallel unregistered imported versions in the country.
Although, the company noted that the original product has been duly registered by NAFDAC, it has not yet been officially imported into Nigeria.
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Dostinex 0.5mg Tablets, manufactured by Pfizer Italia S.R.L, are used to reduce prolactin secretion and manage conditions associated with excess prolactin levels. In other words, the medicine is prescribed to treat hormonal disorders linked to elevated prolactin, which can affect reproductive health and other bodily functions.
Affected batches
In the alert, NAFDAC identified three affected batches currently in circulation: GG3470 with an expiry date of June 2027; LG8659 with an expiry date of January 2026; and GG2440 with an expiry date of April 2026.
The agency noted that the products bear no NAFDAC registration number.
It warned that the potency of medicines depends heavily on compliance with regulatory standards.
Falsified, unlicensed and unregistered medicines, the agency noted, pose significant public health risks because they have not undergone evaluation by the agency, meaning their quality, safety and efficacy cannot be guaranteed.
Surveillance and public advisory
NAFDAC said all its zonal directors and state coordinators have been directed to carry out surveillance and mop up the unregistered products wherever they are found.
The agency advised distributors, retailers, healthcare professionals and caregivers to be vigilant within the supply chain to avoid the distribution, sale and use of the unregistered medicine.
It stressed that medical products should only be obtained from authorised and licensed suppliers, and that their authenticity and physical condition should be carefully checked.
Healthcare professionals were also urged to review stocks in hospitals, clinics and pharmacies and report any suspected falsified or compromised medicines or medical devices to the nearest NAFDAC office.
Reports can also be made through the agency’s toll-free line, designated email addresses, or via the e-reporting platforms available on its website and the Med-safety application.
Reaffirming its mandate, NAFDAC said it remains committed to safeguarding public health and will continue surveillance activities to ensure the quality, safety and efficacy of medicines circulating in Nigeria.
Expanding regulatory scrutiny
The warning on falsified Dostinex adds to a widening enforcement action by NAFDAC which in recent weeks has intensified operations against counterfeit medicines, banned cosmetics and expired consumables across several states.
Earlier this week, PREMIUM TIMES reported that the agency uncovered and confiscated large volumes of prohibited cosmetic products from a warehouse facility.
The items included hundreds of cartons of Crusader and E45 soaps, as well as Extract Gold whitening soaps, brands previously banned by the federal government over safety concerns.
NAFDAC officials said assorted perfumes, body oils and cooking oils were also discovered during the operation.
The operation followed what the regulator described as one of its most consequential recent crackdowns in the Trade Fair Market area of Lagos, where officials intercepted more than 10 million doses of counterfeit malaria medicines alongside cosmetic products valued at about N3 billion.
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Investigators found injectable anti-malarial drugs, antibiotics and long-prohibited medicines such as Postinor and Analgin, some banned in Nigeria for nearly 15 years, stockpiled inside a three-storey building operating under the guise of a spare parts warehouse.
In a separate operation in Bida, Niger State, NAFDAC sealed 18 warehouses after discovering expired food and beverage products worth over N100 million.
The affected items included non-alcoholic drinks, dairy products, bottled water, confectioneries and pasta stored in facilities around Ndazabo White House along Minna Road and behind Bida Modern Market.
