The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a notification to healthcare providers and the public regarding the discovery of a batch of counterfeit Meronem 1g Injection in Nigeria.
The incident was reported by the Marketing Authorization Holder (MAH) Pfizer, who received the information through a patient notification platform. The report raised concerns about a suspicious purchase of Meronem 1g injection, as the vial content did not dissolve upon reconstitution for use.
Key observations made during the investigation include:
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, failing to meet Pfizer’s specifications.
The batch number and expiry date matched an authentic batch intended for distribution in the Egyptian market.
The vial label, however, appeared consistent with the purported artwork version.
Product details
The details of the counterfeit Meronem are as follows:
What you should know
Meronem (Meropenem trihydrate injection) is an antibiotic used for treating skin and abdominal infections caused by bacteria, as well as meningitis in both adults and children aged 3 months and older.
The use of the counterfeit product poses a significant risk to patients, as its quality and safety are not guaranteed.
Healthcare providers and patients are strongly advised to source medical products only from authorised and licensed suppliers. The authenticity and physical condition of products should be carefully checked before purchase and administration.
Importers, wholesalers, and retailers are urged to exercise vigilance within the supply chain and refrain from engaging in the illegal importation, distribution, and sale of the counterfeit Meronem 1g injection and other substandard medicinal products.
Individuals in possession of the counterfeit product are advised to cease its use immediately and submit it to the nearest NAFDAC office. Seeking prompt medical advice from qualified healthcare professionals is recommended for those who have used the product or experienced adverse reactions/events.
Healthcare professionals and consumers are encouraged to report any suspicions of adverse drug reactions, substandard, or falsified medicines to the nearest NAFDAC office, through the NAFDAC helpline at 0800-162-3322, or via email at sf.alert@nafdac.gov.ng.
Additionally, reporting adverse events or side effects related to medicinal product use can be done through the E-reporting platforms on the NAFDAC website (www.nafdac.gov.ng) or via the Med-safety application available for download on Android and iOS stores or through email at pharmacovigilance@nafdac.gov.ng.
Source: NAFDAC
