The National Agency for Food and Drugs Administration and Control, NAFDAC, has alerted the public to a falsified paracetamol injection mislabeled as “Paracetamol Injection 300 mg/2 ml I.M.I.V Aminoglycoside Antibacterial.”
The agency said the product was discovered during a surveillance activity carried out by the post-marketing surveillance unit of the agency in Abuja.
In the public alert issued on February 15, the agency said the falsified product was sampled for laboratory analysis, and the results of the analysis conducted on the product by its 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.
NAFDAC clarified that 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.
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“It is registered by NAFDAC as an analgesic and not an aminoglycoside antibacterial. The Certificate of Registration Holder, Sifam Life Care Pharmaceutical Ltd has confirmed the product to be a falsified paracetamol injection,” it said.
Product details
The details of the falsified paracetamol injection are as follows; Product NameParacetamol Injection 300mg/2ml I.M I.V Aminoglycoside antibacterial
Stated Marketer: Sifam Life Care Pharmaceutical Ltd. No. 33 Keffi Street, Kano, Nigeria.
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.
The agency advised importers, distributors, retailers, healthcare professionals, and caregivers 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”, the agency said
