The NAFDAC has issued a warning to Nigerians, especially healthcare providers, regarding a counterfeit batch of Meronem 1g injection found being sold in Nigeria. This alert, detailed in public alert No. 036/2023 and signed by Prof. Mojisola Adeyeye, the Director-General of the agency, was released to the News Agency of Nigeria (NAN) in Abuja.
Adeyeye highlighted that Pfizer, the Marketing Authorization Holder (MAH), brought this issue to their attention after receiving reports through a patient notification platform about a suspicious purchase of Meronem 1g injection. According to Pfizer, the contents of the vial did not dissolve properly upon reconstitution for use, and upon further inspection, discrepancies in the packaging were noted.
The discrepancy involved the crimp code not matching the code indicated in the production documentation batch of 2A21F11, which was the semi-finished batch used for 4A21I17. This non-matching code indicated that the production process did not meet Pfizer’s specified standards.
“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,” Adeyeye said.
The head of NAFDAC emphasized the importance of sourcing medical products solely from authorized or licensed suppliers for healthcare providers and patients. Stressing the need for verifying product authenticity and physical condition before purchase and use, she urged caution.
Furthermore, she urged importers, wholesalers, and retailers to uphold vigilance in the supply chain and refrain from illegal activities involving the importation, distribution, or sale of counterfeit Meronem 1g injection and other substandard medicinal items.
Adeyeye advised anyone in possession of the counterfeit product to discontinue its use and deliver it to the nearest NAFDAC office. Additionally, she encouraged individuals who had used the counterfeit product or experienced adverse reactions to promptly seek medical advice from qualified healthcare professionals.
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