NIGERIA — The National Agency for Food and Drug Administration and Control (NAFDAC) has raised a red flag, particularly for healthcare providers, regarding the presence of a counterfeit batch of Meronem 1g Injection circulating in Nigeria.

Prof. Mojisola Adeyeye, the Director-General of NAFDAC, issued the cautionary alert during a statement in Abuja, highlighting the potential risks associated with the use of this fraudulent pharmaceutical product.

Pfizer, the Marketing Authorization Holder (MAH), reported the incident to NAFDAC through a patient notification mechanism, shedding light on a suspicious transaction involving Meronem 1g injectable.

Upon further investigation, it was revealed that the contents of the vial failed to dissolve properly when reconstituted for use.

This discrepancy, coupled with a mismatch in the crimp code compared to the production documentation batch, signaled a departure from Pfizer’s stringent quality control standards.

Adeyeye emphasized that the manufacturing procedure of the counterfeit Meronem 1g Injection did not adhere to Pfizer’s requirements.

This lack of adherence poses a considerable risk to patients, as the compromised quality and safety of the product could lead to adverse health effects.

Meronem, which contains Meropenem trihydrate injection, is an antibiotic crucial for treating skin and abdominal infections caused by bacteria, as well as meningitis in both adults and children aged three months and older.

The Director-General pointed out that the vial label presented a deceptive resemblance to the authentic product’s artwork version.

The potential consequences of administering the counterfeit Meronem 1g Injection are severe, posing a heightened risk to patients who rely on the antibiotic for various medical conditions.

Adeyeye urged both patients and healthcare professionals to exercise caution, emphasizing the necessity of obtaining medical supplies exclusively from approved and licensed vendors.

NAFDAC affirms commitment to high standards

In a separate development, NAFDAC reiterated its commitment to maintaining high standards in the face of a facility tour at Colexa Biosensor Limited, the first In-vitro Diagnostics (IVD) manufacturing site in Lagos.

The company specializes in producing glucometers and medical devices for early diabetes diagnosis. Adeyeye emphasized the need for continuous availability of high-quality products to compete globally.

A glucometer, also known as a blood glucose meter or blood sugar meter, is an essential medical device used for measuring the approximate concentration of glucose in the blood.

Colexa Biosensor Limited’s achievement in being the first to produce glucometers domestically is recognized as a groundbreaking development in healthcare technology.

Adeyeye highlighted the transformative potential of manufacturing blood glucose meters and strips within Nigeria, anticipating positive impacts on healthcare and the lives of people living with diabetes.

However, Adeyeye stressed the importance of continuous availability of high-quality products that meet global standards.

This is crucial for Nigerian companies to compete favorably on the international stage, particularly against counterparts from Europe and the United States.

Adeyeye, referencing FDA standards as globally accepted, expressed the agency’s commitment to collaborating with Colexa Biosensor Limited to ensure regulatory compliance.

This collaboration aims to provide necessary guidance and assistance, aligning with global best practices and Good Manufacturing Practices (GMP).

In a bid to address the persistent issue of out-of-stock syndrome in the country’s health facilities, NAFDAC has collaborated with the National Health Insurance Authority (NHIA).

Recently signing a Memorandum of Understanding (MoU) with 12 pharmaceutical companies and drug management organizations, NHIA aims to produce 33 different drugs.

The collaboration with NAFDAC ensures that every drug manufactured meets certified standards for quality, safety, and efficacy.

This collaboration extends beyond manufacturing to encompass the certification and approval of drugs to meet stringent quality and safety.

For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channelfollow us on Twitter and LinkedIn, and like us on Facebook.