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NAFDAC Alerts Public, Healthcare Providers to Counterfeit Meronem 1g Injection
NAFDAC Alerts Public, Healthcare Providers to Counterfeit Meronem 1g Injection
The National Agency for Food and Drugs Administration and Control (NAFDAC) has issued a public alert, particularly directed at healthcare providers, regarding a batch of counterfeit Meronem 1g Injection circulating in the country
The alert, numbered 036/2023, was released on Tuesday and signed by the Director-General of NAFDAC, Prof. Mojisola Adeyeye, in Abuja.
Adeyeye conveyed that NAFDAC received notification about the counterfeit injection from Pfizer, the Marketing Authorisation Holder, who reported the incident through a patient notification platform.
According to Pfizer’s report, the vial content failed to dissolve upon reconstitution for use, and further visual inspection revealed discrepancies in the pack.
The crimp code on the counterfeit product did not match the code reported on the production documentation batch of 2A21F11, which is the semi-finished batch utilized for 4A21I17.
Adeyeye emphasized that the production process did not meet Pfizer’s specifications. She noted, “The vial label compares favourably to the purported artwork version.”
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Meronem (Meropenem trihydrate injection) is an antibiotic used to treat various infections, including skin and abdominal infections caused by bacteria and meningitis in both adults and children aged 3 months and older.
Adeyeye highlighted the significant risk posed to patients by the use of the counterfeit product, as its quality and safety cannot be guaranteed.
Adeyeye urged careful verification of the authenticity and physical condition of the products before purchase and administration. Importers, wholesalers, and retailers were warned against engaging in the illegal importation, distribution, and sale of counterfeit Meronem 1g injection and other substandard medicinal products.
Individuals in possession of the counterfeit product are urged to discontinue its use and submit it to the nearest NAFDAC office. Adeyeye stressed the importance of seeking immediate medical advice from qualified healthcare professionals if any adverse reactions are experienced after using the counterfeit product.
To enhance pharmacovigilance, Adeyeye encouraged healthcare professionals and consumers to report any suspicion of adverse drug reactions, substandard, or falsified medicines to the nearest NAFDAC office. Reports can be made through the NAFDAC phone number at 0800-162-3322 or via email at sf.alert@nafdac.gov.ng.
Furthermore, Adeyeye urged the public to report adverse effects of the product through the Med-safety application available for download on Android and IOS stores or via email at pharmacovigilance@nafdac.gov.ng. The collective efforts of healthcare professionals and the public are crucial in maintaining the safety and integrity of medicinal products in the country.
