The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted Nigerians, particularly healthcare providers, over the one batch of counterfeit Meronem 1g injection being purchased in the country.
This was contained in a statement issued by the Director-General of NAFDAC, Prof. Mojisola Adeyeye, on Tuesday, November 21, 2023.
Adeyeye said the Marketing Authorization Holder (MAH) Pfizer, reported the incident, as received through a patient notification platform, concerning a suspicious park of Meronem 1g injection purchase.
She quoted Pfizer as saying that the vial content did not dissolve when reconstituted for use and that further visual inspection of the pack was observed.
It was also reported that the crimp code did not match the code reported on the production documentation batch of 2A21F11, which is the semi-finished batch used for 4A21I17.
The NAFDAC boss stated that the production process did not meet Pfizer’s specifications.
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Adeyeye noted: “The vial label compares favourably to the purported artwork version.
“Meronem (Meropenem trihydrate injection) is an antibiotic used to treat skin and abdominal (stomach area) infections caused by bacteria and meningitis (infection of the membranes that surround the brain and spinal cord) in adults and children 3 months of age and older.
“The administration of the counterfeit product will pose a high risk to patients as the quality and safety are not guaranteed.”
The NAFDAC DG, however, enjoined healthcare providers and patients to obtain all medical products from authorised/licensed suppliers, adding that products’ authenticity and physical condition should be carefully checked before purchase and administration.
She also implored importers, wholesalers, and retailers to maintain vigilance within the supply chain and desist from illegal importation, distribution, and sale of counterfeit Meronem 1g injection and other substandard medicinal products.
Adeyeye said anybody in possession of the counterfeit product should stop using it, as well as submit it to the nearest NAFDAC office.
She also called on those with possession of the counterfeit product to seek immediate medical advice from a qualified healthcare professional if they already used the product, or suffered from any adverse reaction after using the product.
The NAFDAC boss equally advised healthcare professionals and consumers to report any suspicion of adverse drug reactions, or substandard and falsified medicines to the nearest NAFDAC office.
