The National Agency for Food and Drug Administration and Control (NAFDAC) has warned Nigerians, particularly healthcare providers, against a batch of counterfeit Meronem 1g injection being sold in the country.
The warning was made in a public alert No. 036/2023 signed by the Director-General of the agency, Prof. Mojisola Adeyeye, on Tuesday.
Adeyeye said the Marketing Authorisation holder, Pfizer, reported the incident, as received through a patient notification platform, concerning a suspicious pack of Meronem 1g injection purchase.
She quoted Pfizer as saying that the content did not dissolve when reconstituted for use and that further visual inspection of the pack was then observed.
It was also learned 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 DG said that the production process did not meet with Pfizer’s specifications.
“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 three 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,” Mrs Adeyeye said.
The NAFDAC boss, however, said that healthcare providers and patients were advised to obtain all medical products from authorised/licensed suppliers.
According to her, 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 the counterfeit Meronem 1g injection and other substandard medicinal products.
Mrs Adeyeye said that anybody in the possession of the counterfeit product should stop using it, as well as submit it to the nearest NAFDAC office.
She also called on those in 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 DG also advised healthcare professionals and consumers to report any suspicion of adverse drug reactions or substandard and falsified medicines to the nearest NAFDAC office.