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NAFDAC Raises Alarm Over Counterfeit Dostinex Tablets in Circulation

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The National Agency for Food and Drug Administration and Control has issued a public warning to healthcare providers, patients, and distributors over the circulation of falsified and parallel imported batches of Dostinex 0.5mg Tablets in Nigeria.

In Public Alert No 07 2026 titled Alert on Surveillance and mop up of Counterfeit Dostinex 0.5mg tablets Found in Circulation, the agency identified three affected batch numbers GG3470 LG8659 and GG2440 with expiry dates June 2027 January 2026 and April 2026 respectively.

According to NAFDAC, the product is manufactured by Pfizer Italia S R L located in Ascoli Piceno Italy. However, the circulating batches carry no NAFDAC registration number. The agency disclosed that Pfizer Nigeria Ltd the Marketing Authorisation Holder confirmed the presence of falsified and parallel unregistered imports. It further noted that although the genuine product has been registered it has not yet been officially imported into Nigeria.

Dostinex 0.5mg is prescribed to reduce prolactin secretion and manage conditions linked to excess prolactin levels. NAFDAC stressed that the safety quality and efficacy of medicines depend strictly on regulatory compliance. Falsified unlicensed and unregistered products pose serious public health risks because they have not undergone proper evaluation.

The agency has directed its zonal directors and state coordinators to intensify surveillance and remove the affected products wherever found. Distributors retailers healthcare professionals and caregivers have been advised to remain vigilant and ensure that all medical products are sourced only from authorised and licensed suppliers.

Healthcare providers are urged to review their stock and report any suspected falsified medicines to the nearest NAFDAC office or through its official reporting channels. Patients are also encouraged to report adverse reactions or suious products to safeguard public health.

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