NAFDAC Issues Alert on Falsified Cikatem Anti-Malaria Suspension: Public Urged to Exercise Caution
The National Agency for Food and Drug Administration and Control (NAFDAC) has issued Public Alert No. 05/2025, warning the public about the circulation of falsified Cikatem (Artemether 180 mg/Lumefantrine 1080 mg) suspension bearing a fraudulent NAFDAC Registration Number NRN A11-100025.
Discovery of the Falsified Product
The falsified Cikatem suspension was uncovered at the Coordinated Wholesale Centre (CWC) in Kano following a consumer complaint investigated by NAFDAC's post-marketing surveillance (PMS) officers. The investigation revealed that the product's packaging displayed NAFDAC Registration Number A11-100025, which is assigned to Cikatem Tablet 20/120 mg, not the suspension formulation. Consequently, 17,280 bottles of the falsified suspension were seized at the manufacturing facility and are slated for destruction.
Health Risks Associated with Falsified Medicines
Counterfeit or falsified medicines pose significant health risks as they do not comply with regulatory standards, compromising their safety, quality, and efficacy. The use of such medicines can lead to treatment failure and serious health consequences, including death.
Product Details
Product Name: Cikatem Suspension (Artemether 180 mg/Lumefantrine 1080 mg)
Batch Number: ALS063
Manufacturing Date: October 2024
Expiry Date: September 2027
NAFDAC Registration Number: NRN A11-100025
Manufacturer: Michelle Laboratories
Manufacturer Address: Plot 23, Block 2, Thinkers Corner Industrial Layout, P.O. Box 2709, Enugu, Nigeria
NAFDAC's Actions and Recommendations
NAFDAC has directed all zonal directors and state coordinators to conduct surveillance and remove the counterfeit products from circulation. Distributors, retailers, healthcare professionals, and caregivers are advised to exercise caution and ensure that medical products are sourced from authorized suppliers. The authenticity and physical condition of products should be thoroughly checked.
Reporting Channels
Suspected cases of substandard or falsified medicines should be reported to the nearest NAFDAC office, via the toll-free line 0800-162-3322, or by email at sf.alert@nafdac.gov.ng. Adverse events or side effects can be reported through the Med-Safety app, available on Android and iOS platforms, or by emailing pharmacovigilance@nafdac.gov.ng.
Conclusion
The circulation of falsified Cikatem suspension underscores the critical need for vigilance in the pharmaceutical supply chain. NAFDAC's proactive measures aim to safeguard public health by ensuring that only genuine and effective medications are available to consumers.
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