The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting the public about the circulation of an unauthorized and unregistered Risperdal 2 mg tablet brand formulation in Nigeria, specifically in Kaduna state.
According to Johnson & Johnson, the Marketing Authorization Holder (MAH), the product batch mentioned in this alert has been confirmed as unauthorized for sale in Nigeria. An internal investigation conducted by the MAH revealed that the batch was intended for the Turkish market but was illegally diverted to Nigeria.
The product was purchased outside the authorized distribution network of Johnson & Johnson in Nigeria.
Risperdal 2 mg Tablet is used to treat schizophrenia. It is also used alone or in combination with other medicines to treat mania or mixed episodes (mania and depression) in adults and children above 10 years with bipolar disorder. Risperdal 2 mg Tablet is also used to treat behavioural problems in children aged 5 to 16 years with autism.
Risk Statement
Using unregistered drugs carries serious public health risks, such as potential poisoning, treatment failure, and even death. The safety, quality, and effectiveness of unregistered products cannot be assured, as they have not undergone the necessary evaluations by NAFDAC.
Pharmaceutical products bought from unauthorized or unregistered sources may be counterfeited, falsified, stolen, recalled, or not approved by local regulatory authorities.
Product details
The details of the unregistered batch are as follows.
Product Name | Batch Number | Expiry date |
Risperdal 2 mg tablet | ELB01723 | 02-2026 |
It is important to note that:
The product pack of the unregistered product differs from the artwork of the registered brand in Nigeria.
Photo
Figure 1: Picture shot of diverted/unregistered product
Figure 2: Picture shot of registered brand artwork
All NAFDAC zonal directors and state coordinators have been instructed to conduct surveillance and remove any unregistered products found within their zones and states.
Importers, distributors, retailers, healthcare professionals, and caregivers are advised to exercise caution and vigilance in the supply chain to prevent the importation, distribution, sale, and use of counterfeit products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, NAFDAC on 0800-162-3322, or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng, or via the Med-safety application available for download on Android and IOS stores, or via e-mail on pharmacovigilance@nafdac.gov.ng
Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
NAFDAC………. Customer-focused, Agency-minded!!!
Signed Management
