The National Agency for Food and Drug Administration and Control, NAFDAC, has alerted Nigerians, particularly healthcare providers, to one batch of counterfeit Meronem 1g Injection being purchased in Nigeria.
The information is contained in a public alert No. 036/2023, signed by the Director-General of the agency, Prof. Mojisola Adeyeye, and issued to the News Agency of Nigeria in Abuja on Tuesday.
Mrs 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 reported 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 D-G said that the production process did not meet with the 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 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,” 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 with the 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 D-G also advised healthcare professionals and consumers to report any suspicion of adverse drug reactions, or substandard and falsified medicines to the nearest NAFDAC office, or NAFDAC phone number on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng.
Mrs Adeyeye also encouraged healthcare professionals and patients to report adverse events or side effects related to the use of a medicinal product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng.
The public are also urged to report any adverse effect of the product via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng.
NAN
