The National Agency for Food and Drug Administration and Control (NAFDAC) has cautioned Nigerians against the use and distribution of an unauthorised and unregistered brand of Risperdal 2 mg tablets currently circulating in the country, with confirmed reports from Kaduna State.
In a public alert shared on Saturday, the agency disclosed that the affected Risperdal 2 mg tablet batch was not approved for sale or distribution in Nigeria. Johnson & Johnson, the Marketing Authorisation Holder for Risperdal, confirmed that the product was illegally diverted into the Nigerian market after being manufactured for distribution in Turkey.
NAFDAC explained that investigations by the manufacturer revealed the product did not pass through the company’s authorised supply chain in Nigeria, raising serious concerns about its authenticity, safety, and quality.
Risperdal is an antipsychotic medication commonly prescribed for the management of schizophrenia.
It is also used in the treatment of manic or mixed episodes associated with bipolar disorder in adults and children above the age of 10, as well as behavioural disorders in children aged between five and 16-year with autism.
The agency warned that the use of unregistered medicines poses significant public health risks, including treatment failure, adverse reactions, poisoning, and in extreme cases, death.
NAFDAC stressed that unregistered pharmaceutical products have not undergone the necessary regulatory assessment to guarantee their safety, quality, and effectiveness.
According to the regulator, medicines obtained from unauthorised sources may be counterfeit, falsified, stolen, recalled, or not approved by relevant regulatory authorities, making them unsafe for consumption.
In response to the development, NAFDAC has directed all zonal directors and state coordinators to intensify market surveillance and promptly remove any unregistered Risperdal products found within their jurisdictions.
Healthcare professionals, pharmacists, and members of the public have been urged to remain vigilant and to report any suspected cases of substandard or falsified medicines. Reports can be made at the nearest NAFDAC office, through the agency’s toll-free line on 0800-162-3322, or via email at [email protected].
NAFDAC reaffirmed its commitment to safeguarding public health and urged Nigerians to always purchase medicines from licensed and authorised outlets to reduce the risk of exposure to unsafe pharmaceutical products.
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