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 in circulation across the country.
The information is contained in a public alert Number 036/2023 by the agency’s Director General, Prof. Mojisola Adeyeye, and issued to the News Agency of Nigeria (NAN) yesterday in Abuja.
Adeyeye said the Marketing Authorisation Holder (MAH), Pfizer, reported the incident, as received through a patient notification platform on a suspicious park of Meronem 1g injection purchase.
She quoted Pfizer as saying 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.
Adeyeye said the production process did not meet 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 from three months old and older.
“The administration of the counterfeit product will pose a high risk to patients as the quality and safety are not guaranteed”, she said.
The NAFDAC boss said healthcare providers and patients were advised to obtain all medical products from authorised/licensed suppliers.
She advised that products’ authenticity and physical condition should be carefully checked before purchase and administration.
Adeyeye 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.
The NAFDAC boss said anybody in possession of the counterfeit product should stop using it and submit it to the nearest NAFDAC office.
She also urged those with possession of the counterfeit product to seek immediate medical advice from a qualified healthcare professional, if they have used the product, or suffered from any adverse reaction after using the product.
Adeyeye 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 at 0800-162-3322 or via email: sf.alert@nafdac.gov.ng.
The NAFDAC also urged 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.
She advised members of the public 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.
