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Here is the list of the 40 withdrawn drugs and 4 canceled products as per NAFDAC’s 2024 regulatory actions:
Withdrawn drugs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.
