The National Agency for Food and Drug Administration and Control has warned healthcare providers, patients, and the public about falsified versions of Dostinex 0.5mg tablets circulating in Nigeria.
This alert was issued in a public notice by the agency following confirmation from Pfizer Nigeria Ltd, the product’s marketing authorization holder.
The warning comes amid concerns that unregistered and parallel-imported medicines pose serious public health risks.
What NAFDAC said
According to NAFDAC, falsified and parallel unregistered versions of Dostinex 0.5mg tablets have been identified in circulation, even though the legitimately registered product has not yet been imported into Nigeria.
- “Pfizer Nigeria Ltd, the Marketing Authorization Holder (MAH) of the products, has confirmed the presence of falsified and parallel unregistered imported versions of these products. According to Pfizer Nigeria Ltd, the legitimate product has been registered but has not yet been imported into Nigeria.
- “Dostinex 0.5 mg is a medication that reduces prolactin secretion, helping to alleviate symptoms caused by excess prolactin,” they said
The product details are:
- Batch numbers: GG3470, LG8659, GG2440
- Expiry dates: June 2027, January 2026, April 2026
- NAFDAC registration number: None
- Manufacturer: Pfizer Italia S.R.L., Ascoli Piceno, Italy
NAFDAC stated that falsified, unlicensed, or unregistered medicines have not been evaluated by the agency, meaning their quality, safety, and effectiveness cannot be guaranteed.
More insights
All zonal directors and state coordinators have been directed to carry out surveillance and remove the unregistered products wherever found.
Distributors, retailers, healthcare professionals, and caregivers are advised to exercise vigilance and ensure medicines are sourced only from authorized and licensed suppliers. Healthcare facilities are urged to review existing stock and report suspected falsified or compromised products to the nearest NAFDAC office.
Patients are also encouraged to report adverse reactions or side effects through NAFDAC offices, the agency’s e-reporting platforms, or the Med-safety mobile application. The agency said an alert will be uploaded to the World Health Organization Global Surveillance and Monitoring System to support international tracking of falsified medical products.
What you should know
The National Agency for Food and Drug Administration and Control has repeatedly warned that falsified, tampered, and unregistered health products pose serious risks to public safety.
In a recent safety alert, the agency flagged a suspected revalidated SMA Gold infant formula discovered in Kaduna State after altered expiry dates were linked to illness in a four-month-old infant.
- In one major operation in Lagos, NAFDAC intercepted counterfeit malaria medicines valued at over N1.2 billion hidden in a warehouse, with the fake drugs illegally imported and disguised as other goods before being seized by agency operatives.
- NAFDAC has also destroyed unwholesome and expired medical products valued at more than N15 billion in Ibadan, removing falsified and harmful drugs from circulation to protect public health.
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