The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert (No. 036/2023) warning Nigerians, especially healthcare providers, about a batch of counterfeit Meronem 1g Injection circulating in Nigeria. The alert, signed by NAFDAC’s Director-General, Prof. Mojisola Adeyeye, was released on Tuesday in Abuja.
According to Adeyeye, Pfizer, the Marketing Authorization Holder (MAH), reported the incident after receiving information through a patient notification platform. The report highlighted concerns about a suspicious batch of Meronem 1g injection, stating that the vial content failed to dissolve when reconstituted for use. Further visual inspection revealed discrepancies in the pack.
Pfizer also noted that the crimp code on the counterfeit batch did not match the code documented for the production batch 2A21F11, which serves as the semi-finished batch for 4A21I17.
The D-G said that the production process did not meet with the Pfizer’s specifications.
“The vial label compares favorably 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 authorized/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 illegal importation, distribution, and sale of the counterfeit Meronem 1g injection and other substandard medicinal products. Adeyeye said that anybody in the possession of the counterfeit product should stop using it, as well as submit it to the nearest NAFDAC office.
She urged individuals in possession of the counterfeit product to promptly seek medical advice from qualified healthcare professionals if they have already used the product or experienced any adverse reactions. The Director-General advised healthcare professionals and consumers to report any suspicions of adverse drug reactions or encounters with substandard and falsified medicines to the nearest NAFDAC office. Reports can also be made through the NAFDAC phone number at 0800-162-3322 or via email at sf.alert@nafdac.gov.ng.
Adeyeye further encouraged healthcare professionals and patients to report adverse events or side effects associated with the use of medicinal products. Reports can be submitted to the nearest NAFDAC office or through the E-reporting platforms available on the NAFDAC website, www.nafdac.gov.ng. Additionally, the public is urged to report any adverse effects of the product using the Med-safety application, accessible for download on Android and IOS stores, or through email at pharmacovigilance@nafdac.gov.ng.