The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying healthcare providers and the public that one batch of counterfeit Meronem 1g Injection has been purchased in Nigeria.
The Marketing Authorization Holder (MAH) Pfizer reported the incident as received through a patient notification platform, concerning a suspicious park of Meronem 1g injection purchase.
According to Pfizer, the vial content did not dissolve when reconstituted for use. On further visual inspection of the pack, it was observed that;
- The crimp code does not match the code reported on the production documentation batch of 2A21F11 which is the semi-finished batch used for 4A21I17. This does not meet with the Pfizer’s specifications.
- The batch number and expiry date match an authentic batch of Meronem 1g injection intended for distribution in the Egyptian market.
- 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.
Healthcare providers and patients are advised to obtain all medical products from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked before purchase and administration.
All importers, wholesalers and retailers are implored to maintain vigilance within the supply chain and desist from illegal importation, distribution, and sale of the counterfeit Meronem 1g injection and other counterfeit and substandard medicinal products.
Anybody possessing the counterfeit product should stop using it and submit it to the nearest NAFDAC office. Seek immediate medical advice from a qualified healthcare professional if you have used the product, or you suffered an adverse reaction/event having used the product.
Healthcare professionals and consumers are advised to report any suspicion of adverse drug reactions, or substandard and falsified medicines to the nearest NAFDAC office, NAFDAC 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Healthcare professionals and patients are also encouraged 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 or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
