The National Agency for Food and Drug Administration and Control (NAFDAC) has taken significant steps in 2024 to safeguard public health, including the withdrawal of 40 pharmaceutical products by market authorization holders, the cancellation of four drugs, and the ban of harmful food and dietary items.
The agency has demonstrated its commitment to safeguarding public health by intensifying the regulation and oversight of drugs, food, and other consumables in Nigeria.
Through recalls, withdrawals, cancellations, and bans, the agency took decisive steps to eliminate substandard, contaminated, or harmful products from the market.
To ensure long-term impact, NAFDAC has emphasized stricter compliance requirements for manufacturers, including robust quality control measures and transparent supply chains.
Major recalls and regulatory actions
NAFDAC issued multiple public alerts this year, emphasize the breadth of its oversight and regulatory interventions:
Drug recalls to safeguard patients
- Deekins Amoxycillin 500mg Capsule (Batch 4C639001)
Following reports of severe adverse drug reactions, NAFDAC recalled this antibiotic indicated for treating bacterial infections, emphasizing the critical need for safety in essential medicines, and alerted the public on the 3rd of December 2024 because an adverse reaction to drugs may be life-threatening.
- Acetazolamide Tablets USP 125mg (Batch 30575HF1)
On November 26, 2024, NAFDAC recalled these tablets, manufactured by an American pharmaceutical company, Rubicon Research Private Ltd.
The company recalled the affected drug due to contamination, dirty, and discolored tablets. Acetazolamide is a diuretic used in the treatment of swelling caused by heart disease.
The use of contaminated drugs can result in potential poisoning and treatment failures for patients with glaucoma and epilepsy.
- Two batches of Pantogen Injection “Singtong” (Batches 4DM1150 and 4DM0442)
Abnormal colour complaints led to the recall of this vitamin supplement injection; it was initiated by the manufacturer following received customer complaints. The drug was recalled by NAFDAC safeguarding patients. On November 26, the agency alerted the public.
Food and dietary product regulation
Ban on Brominated Vegetable Oil (BVO): NAFDAC supported the global ban on BVO, a substance linked to thyroid damage and central nervous system risks. The prohibition aligns Nigeria with international food safety standards.
It has been shown to pose toxic risks to the thyroid and cause other chronic health problems. The rule of the ban was effective from August 2, 2024.
The agency said it is important to note that Brominated vegetable oil (BVO) is not used in Nigeria or many other countries due to its potential health risks.
Weight Loss Products with Banned Substances: The agency warned against detox slimming sachets, products were discovered to contain banned medicinal substances of sibutramine and sennosides associated with severe cardiovascular and gastrointestinal risks.
Here is the list of the 40 withdrawn drugs and 4 canceled products as per NAFDAC’s 2024 regulatory actions:
Withdrawn drugs
- Abacavir Sulfate/Lamivudine Dispersible Tablets 60mg/30mg – Healthline Limited
- Amaryl M Tablets – Sanofi Aventis Nigeria Ltd
- Amaryl M SR Tablets – Sanofi Aventis Nigeria Ltd
- Aprovasc 150mg/5mg Tablets – Sanofi Aventis Nigeria Ltd
- Artemether/Lumefantrine 40mg/240mg Tablets – Healthline Limited
- ASAQ (Artesunate Amodiaquine Winthrop) 100mg/270mg Tablets – Sanofi Aventis Nigeria Ltd
- ASAQ (Artesunate Amodiaquine Winthrop) 25mg/67.5mg Tablets – Sanofi Aventis Nigeria Ltd
- ASAQ (Artesunate Amodiaquine Winthrop) 50mg/135mg Tablets – Sanofi Aventis Nigeria Ltd
- Betopic Eye Drop – Novartis
- Coaprovel 300mg/25mg Tablets – Sanofi Aventis Nigeria Ltd
- Combination 3 Tablets – Bayer East Africa Limited
- Efavirenz 600mg Tablets – Healthline Limited
- Elisca Eye Drop – Sanofi Aventis Nigeria Ltd
- Flagyl Suspension – Sanofi Aventis Nigeria Ltd
- Flagyl Tablet 400mg – Sanofi Aventis Nigeria Ltd
- Iliadin Adult 0.05% Metered Nose Spray – Fensyl MHP Consulting Ltd
- Iliadin Baby 0.01% Nose Drops – Fensyl MHP Consulting Ltd
- Iliadin Kids 0.025% Nose Drops – Fensyl MHP Consulting Ltd
- Invanz 1g Injections – MSD Idea Pharmaceuticals Nigeria Ltd
- Invega (Paliperidone) 3mg Extended-Release Tablets – Janssen Pharmaceutical Companies
- Invega (Paliperidone) 6mg Extended-Release Tablets – Janssen Pharmaceutical Companies
- Invega (Paliperidone) 9mg Extended-Release Tablets – Janssen Pharmaceutical Companies
- Janumet 50mg/1000mg Tablets – MSD Idea Pharmaceuticals Nigeria Ltd
- Janumet 50mg/850mg Tablets – MSD Idea Pharmaceuticals Nigeria Ltd
- Januvia 100mg Tablets – MSD Idea Pharmaceuticals Nigeria Ltd
- Januvia 50mg Tablets – MSD Idea Pharmaceuticals Nigeria Ltd
- Kombiglyze 2.5mg/1000mg Tablets – AstraZeneca
- Kombiglyze 5mg/1000mg Tablets – AstraZeneca
- Lamivudine/Nevirapine/Zidovudine Dispersible Tablets 150mg/200mg/300mg – Healthline Limited
- Lamivudine/Nevirapine/Zidovudine Dispersible Tablets 30mg/50mg/60mg – Healthline Limited
- Lexotan 3mg Tablets – F. Hoffmann-La Roche Ltd.
- Mosegor Syrup – Novartis
- Nevirapine 200mg Tablets – Healthline Limited
- Onglyza 2.5mg Tablets – AstraZeneca
- Onglyza 5mg Tablets – AstraZeneca
- Penicillin G Sodium Sandoz Powder for Solution for Injection – Novartis
- Salbutamol 100mcg Inhaler – Novartis
- Sporanox (Itraconazole) 100mg Capsule – Worldwide Healthcare
- Xyzal Oral Drops – GlaxoSmithKline Pharmaceutical Nigeria Ltd
- Zidovudine 300mg Tablets – Healthline Limited
Cancelled Products
- Uptivite Man Tablets – Gentlehills Limited
- Mist Alba Suspension – Gentlehills Limited
- Gentle Hill Cough Syrup – Gentlehills Limited
- Gentlehills Vitamin C Syrup – Gentlehills Limited
Reasons for withdrawals
NAFDAC stated that the withdrawals were primarily initiated by Market Authorization Holders, who cited challenges such as supply chain issues, regulatory changes, and evolving market dynamics.
The cancellations, on the other hand, were based on non-compliance with safety and efficacy standards.
