Consumer Safety: NAFDAC alerts Nigerians to counterfeit injection in circulation

*The National Agency for Food and Drug Administration and Control warns Nigerians that administration of the counterfeit Meronem 1g Injection will pose a high risk to consumers as the quality and safety of the affected product are not guaranteed

Isola Moses | ConsumerConnect

As part of the health regulator’s ‘customer-focused’ mandate to protect consumers’ well-being, the Management of the National Agency for Food and Drug Administration and Control (NAFDAC) is notifying healthcare providers and the larger Nigerian public that a batch of counterfeit Meronem 1g Injection has been purchased in the country.

ConsumerConnect reports the health sector regulatory agency, which stated this in a Public Alert No. 036/2023 the Management signed, dated and issued Sunday, November 19, 2023, noted the Marketing Authorisation Holder (MAH) Pfizer reported the incident as received through a patient notification platform, concerning a suspicious park of Meronem 1g injection purchase.

NAFDAC said: “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.

The regulator also stated that the healthcare product “does not meet with the Pfizer’s specifications.”

It explained that 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,” NAFDAC warned Nigerian consumers.

Counterfeit injection product details

The health sector regulatory agency has been details of the counterfeit Meronem are as follows:

• Product Name Meronem 1g IV injection
• Stated Manufacturer Pfizer
• Batch Number 4A21I17
• Expiry date 01/2025
• Stated Active Ingredients -Meropenem trihydrate

NAFDAC, therefore,  advised healthcare providers and patients to obtain all medical products from authorised/licensed suppliers.

It urged Nigerians: “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.”

In regard to what to do in safeguarding the health of consumers in possession of the product, the agency said “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.”

It as well advised healthcare professionals and consumers 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.

Likewise, NAFDAC 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 Web site 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.