National Agency for Food and Drug Administration and Control (NAFDAC) said on Tuesday, that it has received a report through its patient notification platform concerning one batch of counterfeit Meronem 1g Injection in circulation.
The Agency alert Nigerians on the development, thus asking individuals or pharmaceutical companies in possession of the counterfeit product to submit the products to the nearest NAFDAC office.
Director-General of NAFDAC, Prof. Mojisola Adeyeye, who signed the public alert No. 036/2023, on Tuesday, added that Pfizer was the Marketing Authorization Holder (MAH) for the product.
She explained that 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 NAFDAC boss said that, according to the MAH, Pfizer, the patient who reported the case noted that the vial content did not dissolve when reconstituted for use and that further visual inspection of the pack was observed.
She said it was also reported that the crimp code on the product did not match the code reported on the production documentation batch of 2A21F11, which is the semi-finished batch used for 4A21I17.
In addition to that, the batch number and expiry date match an authentic batch of Meronem 1g injection intended for distribution in the Egyptian market.
She confirmed that preliminary investigation further indicated that the production process did not meet with the Pfizer’s specifications.
“The vial label compares favourably to the purported artwork version.”
She was concerned that the administration of the counterfeit product will pose a high risk to patients as the quality and safety are not guaranteed.
The NAFDAC boss, however, said that healthcare providers and patients have been advised to obtain all medical products from authorized/licensed suppliers.
She also asked that products’ authenticity and physical condition should be carefully checked before purchase and administration, hence she 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.
She asked those in possession of the counterfeit product to seek immediate medical advice from a qualified healthcare professional if they had already used the product, or suffered from any adverse reaction after using the product.
The NAFDAC boss 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.
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.
