- NAFDAC was notified about the injection by the Marketing Authorisation Holder Pfizer
The National Agency for Food and Drugs Administration and Control has notified the public, particularly healthcare providers, to one batch of counterfeit Meronem 1g Injection being purchased in the country.
The notification of this product is contained in a public alert No. 036/2023, signed by the Director-General of the agency, Prof. Mojisola Adeyeye, on Tuesday, in Abuja.
Adeyeye said that the agency was equally notified about the injection by the Marketing Authorisation Holder Pfizer, who reported the incident, as received through a patient notification platform.
The NAFDAC boss said Pfizer reported 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.
She said that 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 NAFDAC boss, however, said that healthcare providers and patients were advised to obtain all medical products from authorised/licensed suppliers.
She advised that the 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.
She warned that anybody in possession of the counterfeit product should stop using it, adding that it should be submitted to the nearest NAFDAC office.
She also called on those with 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.
Adeyey 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.
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.
She also urged 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.
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