The National Agency for Food and Drugs Administration and Control (NAFDAC) has alerted the public of the sale of a falsified Paracetamol Injection mislabelled as Paracetamol Injection 300mg/2ml I.M I.V Aminoglycoside Antibacterial.
The product, it said, was discovered during a surveillance activity carried out by the post-marketing surveillance (PMS) unit of the Agency in FCT, Abuja.
The falsified product was sampled for laboratory analysis and the result of analysis conducted on the product by NAFDAC Laboratory Kaduna showed that the product contained only paracetamol.
Paracetamol Injection is an analgesic and antipyretic used to treat mild to moderate pain and to reduce fever. It is not an Aminoglycoside Antibacterial as labeled on the product. Aminoglycosides are a class of antibiotics used to treat serious infections caused by bacteria that are difficult to treat.
The genuine Paracetamol Injection 300mg/2ml I.M I.V is manufactured by Shandong Shenglu Pharm. Co. Ltd, China, and marketed by Sifam Life Care Pharmaceutical Ltd, Kano, Nigeria. It is registered by NAFDAC as an analgesic and not aminoglycoside antibacterial. The Certificate of Registration Holder (Sifam Life Care Pharmaceutical Ltd) has confirmed the product to be a falsified paracetamol injection.
All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the falsified product within the zones and states.
Importers, distributors, retailers, healthcare professionals, and caregivers are hereby advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of the falsified product. 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
