In the year 2023, the National Agency for Food and Drug Administration and Control (NAFDAC), a vital federal agency operating under the Ministry of Health in Nigeria, took significant actions in regulating and overseeing the production, importation, exportation, advertisement, distribution, sale, and use of various products, including food, drugs, cosmetics, medical devices, chemicals, and packaged water.
Empowered with the authority to conduct rigorous tests and ensure adherence to approved standard specifications, NAFDAC plays a crucial role in safeguarding public health.
The agency conducts investigations into production facilities and raw materials, establishing pertinent quality assurance systems that include certifying production sites and regulated products.
As part of its responsibilities, NAFDAC conducts inspections of imported products and formulates standard specifications, regulations, and guidelines governing the production, importation, exportation, sale, and distribution of diverse products such as foods, drugs, cosmetics, medical devices, bottled water, and chemicals.
NAFDAC’s Recall Procedure
NAFDAC may initiate a recall or ban on a product due to safety or quality concerns arising from manufacturing or design issues that could pose harm to users.
Drug recalls may be prompted by safety considerations, quality problems, regulatory non-compliance, contamination or adulteration, mislabeling or incorrect packaging, adverse effect reports, or supplier and manufacturing issues.
In the event of a recall, NAFDAC promptly issues alerts to inform the general public and healthcare providers, outlining safety measures to be observed.
Here is a compiled, comprehensive list of drugs recalled by NAFDAC in the year 2023:
Coartem 20/120mg tablets (Green pack)
On the 8th of March, 2023, NAFDAC notified the public of some falsified Coartem 20/120mg tablets (anti-malaria drug).
Green blister packs of Coartem 20/120mg tablets were found in the North Central zone, particularly in Jos.
However, the manufacturer, Novartis confirmed in October 2021 that it no longer manufactured authentic versions of the green blister packs leading NAFDAC to ban the sale of the green blister packs.
Coartem is used to treat uncomplicated malaria.
Two lots of Norvasc 5mg tablets
NAFDAC alerted the public of the recall of six million tablets from two batches of Norvasc 5mg produced by U.S-based drug developer, Viatris on the 28th of March 2023.
The initial recall was done by the Taiwan Food and Drug Administration (FDA) after the discovery of iron wires inside the tablets. Norvasc 5mg is used to treat high blood pressure levels.
Herceptin 600mg/5ml injection
On the 2nd of April 2023, the agency recalled a batch of Herceptin 600mg/5ml after confirming that the counterfeit batch was distributed in Abuja.
According to the marketing holder, Roche, the injection was never shipped to Nigeria. Herceptin is used to treat breast cancer whose tumour is positive for HER2.
Falsified Ozempic (semaglutide) pen
Novo Nordisk confirmed that one batch of Ozempic pens in Nigeria was falsified after receiving an inquiry from a customer. NAFDAC recalled this batch and notified the public on the 2nd of May 2023.
Ozempic is used to treat diabetes in adults. It also helps reduce cardiovascular events in adults with diabetes.
Paracetamol suspension
NAFDAC received substandard paracetamol suspension, Para Clear, from the Republic of Liberia.
Laboratory analysis of the suspension revealed toxic ethylene glycol which can cause altered mental states, acute kidney injury, and death. The drug was banned from the Nigerian market.
Original Chest and Lung tablets
On the 21st of June, 2023, NAFDAC notified the public of an unregistered substandard drug product named “Original chest and lung tablets circulating in Nigeria”.
The product is not in the NAFDAC database and, therefore banned in the Nigerian market.
Dostinex tablets
Following a notification received from Dostinex’s manufacturer disclosing a patient’s complaint, NAFDAC alerted the public on counterfeit Dostinex circulating in Nigeria on the 24th of June 2023.
The agency was unable to get the batch number for recall but warned that counterfeit products had 08/2024 as the expiry date which did not match the expiry captured within the data matrix.
Dostinex is used to treat medical conditions related to the overproduction of the hormone, Prolactin.
Artequin 600/750 tablets
The agency issued an alert following a notification from Occulus Pharmacare Ltd on behalf of Acino Pharma AG, the manufacturers of Artequin, disclosing the distribution of the counterfeit Artequin 600/750 tablets in Onitsha and Kaduna.
Artequin 600/750 mg tablets are used to treat acute uncomplicated malaria infection caused by Plasmodium falciparum.
According to NAFDAC, the license for this medicine has expired and it was formally withdrawn (recalled) and should therefore not be found within the country.
Anthrax vaccines
NAFDAC alerted the public on its discovery of fake anthrax vaccines circulating in Nasarawa, Kaduna, Kwara, and Oyo states on the 1st of September 2023.
Following the current outbreak of anthrax in the country, fake vaccines were sold at major livestock markets in these states.
Laboratory analysis of these fake vaccines revealed that they contained plain water and, in some cases, sugar and water. The original vaccine is still unregistered by NAFDAC.
Meropenem 1g injections
The manufacturing authority holder, Pfizer, reported to NAFDAC after a patient complained that the vial’s contents did not dissolve.
NAFDAC alerted all healthcare professionals and patients on the 19th of November 2023 about a counterfeit batch of the injection. NAFDAC recalled this batch of injections with batch number 4A21I17.
Meropenem is an antibiotic used to treat skin and abdominal areas caused by bacteria and meningitis in adults and children 3 months of age and older.
