NAFDAC Alerts Public on Counterfeit Meronem 1g Injection in Circulation

NAFDAC Has issued a Public Alert, Particularly Directed at Healthcare Providers, Regarding a Batch of Counterfeit Meronem 1g Injection Circulating in the Country

The National Agency for Food and Drug Administration and Control has notified the public, particularly healthcare providers, of one batch of counterfeit Meronem 1g injection being purchased in the country.

Counterfeit drugs pose a significant threat to public health, and the infiltration of counterfeit Meronem 1g injections is a matter of grave concern. Meronem, a broad-spectrum antibiotic, is commonly used in healthcare settings to treat various bacterial infections. The consumption of counterfeit drugs can lead to adverse health effects, treatment failure, and even mortality.

The alert issued by NAFDAC serves as a testament to the agency’s commitment to safeguarding public health. NAFDAC has identified a specific batch of the counterfeit Meronem 1g Injection and is urging healthcare providers, distributors, and the general public to be vigilant. The agency has also provided detailed information about the identified batch, including batch numbers, expiration dates, and packaging details.

Healthcare providers play a crucial role in ensuring patient safety. In light of NAFDAC’s alert, it is imperative for healthcare professionals to thoroughly inspect the Meronem 1g injection before administration. They should cross-verify the batch number, check the packaging for any irregularities, and report any suspicious products to NAFDAC promptly.

The circulation of counterfeit drugs not only jeopardizes individual health but also undermines the efficacy of healthcare systems. Patients may experience treatment failure, increased healthcare costs, and prolonged suffering due to the administration of substandard or ineffective medications. NAFDAC’s alert underscores the need for a coordinated effort to combat the illicit trade of counterfeit drugs.

The notification of this product is contained in a public alert No. 036/2023, signed by the Director-General of the agency, Prof. Mojisola Adeyeye, on Tuesday in Abuja.

Adeyeye said that the agency was equally notified about the injection by the marketing authorization holder, Pfizer, who reported the incident, as received through a patient notification platform.

The NAFDAC boss said Pfizer reported that the vial content did not dissolve when reconstituted for use and that further visual inspection of the pack was observed.

It was also reported that 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.

She said that the production process did not meet Pfizer’s specifications.

“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 NAFDAC boss, however, said that healthcare providers and patients were advised to obtain all medical products from authorized or licensed suppliers.

She advised that the 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.

She warned that anybody in possession of the counterfeit product should stop using it, adding that it should be submitted to the nearest NAFDAC office.

She also called on those with possession of the counterfeit product to seek immediate medical advice from a qualified healthcare professional if they already used the product, or suffered from any adverse reaction after using the product.

Adeyey also advised healthcare professionals and consumers to report any suspicion of adverse drug reactions, or substandard and falsified medicines to the nearest NAFDAC office, or NAFDAC phone number at 0800-162-3322 or via email: [email protected].

Adeyeye also encouraged healthcare professionals and patients 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

She also urged the public to report any adverse effect of the product via the Med- safety application available for download on android and IOS stores or via e-mail on [email protected].

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