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 circulating , and being sold in Nigeria.
The information is contained in a public alert No. 036/2023, signed by the agency’s Director-General, Prof. Mojisola Adeyeye.
Adeyeye said the Marketing Authorisation Holder (MAH), Pfizer, reported the incident, as received through a patient notification platform, concerning a suspicious 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, the semi-finished batch used for 4A21I17. Prof 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 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,” Adeyeye said.
The DG however, said that healthcare providers and patients were advised to obtain all medical products from authorized or 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 the illegal importation, distribution, and sale of counterfeit Meronem 1g injection and other substandard medicinal products.
Adeyeye said that anybody in possession of the counterfeit product should stop using it and submit it to the nearest NAFDAC office.
She called on 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 reactions after using it.