NAFDAC Alerts Public, Healthcare Providers of Counterfeit Meronem 1g Injection
The National Agency for Food and Drugs Administration and Control (NAFDAC) has issued a public alert (No. 036/2023) notifying the public, especially healthcare providers, about a batch of counterfeit Meronem 1g Injection in circulation in the country.
The alert, signed by the Director-General of NAFDAC, Prof. Mojisola Adeyeye, was released on Tuesday in Abuja.
Adeyeye stated that Pfizer, the Marketing Authorisation Holder, reported the incident to the agency after receiving information through a patient notification platform.
Pfizer reported that the vial content did not dissolve when reconstituted for use, and a visual inspection of the pack revealed discrepancies, including a mismatched crimp code with the reported production documentation batch of 2A21F11, a semi-finished batch used for 4A21I17. The production process was found not to meet Pfizer’s specifications.
Meronem (Meropenem trihydrate injection) is an antibiotic used for treating various infections. Adeyeye emphasized that the administration of the counterfeit injection poses a high risk to patients as its quality and safety cannot be guaranteed.
Adeyeye stressed the importance of carefully checking the authenticity and physical condition of medical products before purchase and administration, urging healthcare providers and patients to obtain all medical products from authorized and licensed suppliers only.
Importers, wholesalers, and retailers were cautioned to exercise vigilance within the supply chain and refrain from engaging in illegal importation, distribution, and sale of counterfeit Meronem 1g injection and other substandard medicinal products.
Individuals in possession of the counterfeit product were urged to cease its use and submit it to the nearest NAFDAC office. Adeyeye advised those with possession of the counterfeit product to seek immediate medical advice from qualified healthcare professionals if they had used the product or experienced any adverse reactions.
Adeyeye encouraged healthcare professionals and consumers to report any suspicion of adverse drug reactions, or substandard and falsified medicines to the nearest NAFDAC office or contact NAFDAC via phone at 0800-162-3322 or email at sf.alert@nafdac.gov.ng.
Healthcare professionals and patients were also urged to report adverse events or side effects related to the use of medicinal products to the nearest NAFDAC office or through E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng.
Members of the public were advised to report any adverse effects of the product via the Med-safety application, available for download on Android and IOS stores, or through email at pharmacovigilance@nafdac.gov.ng.