In a sweeping regulatory update, the National Agency for Food and Drug Administration and Control (NAFDAC) has officially announced the immediate withdrawal, suspension, or cancellation of 101 pharmaceutical products across Nigeria.
This decisive move means that the affected products are no longer permitted to be manufactured, imported, exported, distributed, advertised, sold, or used in Nigeria.
What Does It Mean: Withdrawal, Suspension, Cancellation?
NAFDAC’s public notice defines three distinct statuses for registered products.
Withdrawal:
The market authorization holder (i.e., the company holding the registration) elects to discontinue use of the registration.
NAFDAC Suspension:
The product’s registration is temporarily put on hold because it no longer meets the conditions under which the license was issued.
Cancellation:
The certificate of registration is fully revoked by NAFDAC.
In short, a cancelled product has lost its regulatory approval outright, while a suspended product may be reinstated if remedial steps are taken, and a withdrawn product is one the holder no longer wishes to maintain.
Below is the full, verbatim list of 101 products shown on NAFDAC’s official notice “List of Withdrawn, Suspended and Cancelled products as approved by NAFDAC”:
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Abacavir Sulfate/Lamivudine Dispersible Tablets 60mg/30mg Tablets NAFDAC C4-1180 Healthline Limited Withdrawn voluntarily by Market Authorization Holder.
Amaryl M Tablets NAFDAC A4-2619 Glimepiride + Metformin Hydrochloride. Sanofi Aventis Nigeria Ltd Withdrawn voluntarily by Market Authorization Holder.
Amaryl M SR Tablets NAFDAC A4-7296 Glimepiride + Metformin Hydrochloride Sanofi Aventis Nigeria Ltd Withdrawn voluntarily by Market Authorization Holder.
Aprovasc 150mg/5mg tablets NAFDAC B4-2687 Amlodipine Besylate + (co-ingredient) Sanofi Aventis Nigeria Ltd Withdrawn voluntarily by Market authorization holder.
Artemether/Lumefantrine 40mg/240mg Tablets NAFDAC B4-5745 Healthline Limited Withdrawn voluntarily by Market Authorization Holder.
ASAQ (Artesunate amodiaquine Winthrop) 100mg/270mg Tablets NAFDAC A4-3357 Sanofi Aventis Nigeria Ltd Withdrawn voluntarily by Market Authorization Holder.
ASAQ (Artesunate amodiaquine Winthrop) 25mg/67.5mg Tablets Tablets — NAFDAC A4-3406 — Artesunate Amodiaquine Winthrop 25mg/67.5mg — Sanofi Aventis Nigeria Ltd — Withdrawn voluntarily.
ASAQ (Artesunate amodiaquine Winthrop) 50mg/135mg Tablets — Tablets — NAFDAC A4-3405 — Artesunate Amodiaquine Winthrop 50mg/135mg — Sanofi Aventis Nigeria Ltd — Withdrawn voluntarily.
Betopic Eye drop — Eye Drop — NAFDAC 04 2404 — Betaxolol Hydrochloride — Novartis Nigeria Limited — Withdrawn voluntarily by Market Authorization Holder.
Coaprovel 300mg/25mg Tablets — Tablets — NAFDAC B4-2317 — Hydrochlorothiazide + Irbesartan — Sanofi Aventis Nigeria Ltd — Withdrawn voluntarily.
Combination 3 Tablets — Tablet — NAFDAC A4-6459 — Estrogen, Progestin — Bayer East Africa Limited — Withdrawn voluntarily.
Efavirenz 600mg Tablets — Tablets — NAFDAC A4-1318 — Efavirenz 600mg — Healthline Limited — Withdrawn voluntarily.
Elisca eye drop — Eye Drop — NAFDAC 04 2461 — Chloramphenicol Eye Drop — Sanofi Aventis Nigeria Ltd — Withdrawn voluntarily.
Flagyl Suspension — Suspension — NAFDAC A4-3947 — Metronidazole Benzoate — Sanofi Aventis Nigeria Ltd — Withdrawn voluntarily.
Flagyl Tablet 400mg — Tablets — NAFDAC 04 5566 — Metronidazole — Sanofi Aventis Nigeria Ltd — Withdrawn voluntarily.
Iliadin Adult 0.05% Metered Nose Spray — Spray — NAFDAC B4-9913 — Oxymetazoline HCl 0.05% M/V — Fensyl MHP Consulting Ltd — Withdrawn voluntarily.
Iliadin baby 0.01% nose drops — Spray — NAFDAC C4-0106 — Oxymetazoline HCl 0.01% M/V — Fensyl MHP Consulting Ltd — Withdrawn voluntarily.
Iliadin kids 0.025% nose drops — Spray — NAFDAC B4-9912 — Oxymetazoline HCl 0.025% M/V — Fensyl MHP Consulting Ltd — Withdrawn voluntarily.
Invanz 1g Injections — Injectables — NAFDAC 04 8118 — Ertapenem 1g — MSD Idea Pharmaceuticals Nigeria LTD — Withdrawn voluntarily.
Invega (Paliperidone) 3mg extended release tablets — Tablets — NAFDAC B4-8223 — Paliperidone — Janssen Pharmaceutical Companies — Withdrawn voluntarily.
Invega (Paliperidone) 6mg extended release tablets — Tablets — NAFDAC B4-8222 — Paliperidone — Janssen Pharmaceutical Companies — Withdrawn voluntarily.
Invega (Paliperidone) 9mg extended release tablets — Tablets — NAFDAC B4-8221 — Paliperidone — Janssen Pharmaceutical Companies — Withdrawn voluntarily.
Janumet 50mg/1000mg Tablets — Tablets — NAFDAC B4-1771 — Sitagliptin 50mg, Metformin Hydrochloride 1000mg — MSD Idea Pharmaceuticals Nigeria LTD — Withdrawn voluntarily.
Janumet 50mg/850mg Tablets — Tablets — NAFDAC B4-1637 — Sitagliptin 50mg, Metformin Hydrochloride 850mg — MSD Idea Pharmaceuticals Nigeria LTD — Withdrawn voluntarily.
Januvia 100mg Tablets — Tablets — NAFDAC B4-0023 — Sitagliptin 100mg — MSD Idea Pharmaceuticals Nigeria LTD — Withdrawn voluntarily.
Januvia 50mg Tablets — Tablets — NAFDAC B4-0335 — Sitagliptin 50mg — MSD Idea Pharmaceuticals Nigeria LTD — Withdrawn voluntarily.
Kombiglyze 2.5mg/1000mg tablets — Tablets — NAFDAC A4-9646 — Saxagliptin, Metformin HCl — AstraZeneca Nigeria Limited — Withdrawn voluntarily.
Kombiglyze 5mg/1000mg tablets — Tablets — NAFDAC A4-9645 — Saxagliptin, Metformin HCl — AstraZeneca Nigeria Limited — Withdrawn voluntarily.
Lamivudine/Nevirapine/Zidovudine Dispersible Tablets 150mg/200mg/300mg — Tablets — NAFDAC A4-2813 — Lamivudine/Nevirapine/Zidovudine — Healthline Limited — Withdrawn voluntarily.
Lamivudine/Nevirapine/Zidovudine Dispersible Tablets 30mg/50mg/60mg — Tablets — NAFDAC A4-1319 — Lamivudine/Nevirapine/Zidovudine — Healthline Limited — Withdrawn voluntarily.
Lexotan 3mg Tablets — Tablets — NAFDAC 04 8808 — Bromazepam — F. Hoffmann-La Roche Ltd. — Withdrawn voluntarily.
Mosegor Syrup — Syrup — NAFDAC 04 8106 — Pizotifen 0.05mg/ml — Novartis Nigeria Limited — Withdrawn voluntarily.
Nevirapine Tablets 200mg — Tablets — NAFDAC A4-1431 — Nevirapine 200mg — Healthline Limited — Withdrawn voluntarily.
Onglyza 2.5mg tablets — Tablets — NAFDAC A4-8864 — Saxagliptin — AstraZeneca Nigeria Limited — Withdrawn voluntarily.
Onglyza 5mg tablets — Tablets — NAFDAC A4-8863 — Saxagliptin — AstraZeneca Nigeria Limited — Withdrawn voluntarily.
Penicillin G Sodium Sandoz Powder for Solution for Injection — Injectables — NAFDAC B4-6367 — Benzylpenicillin 1,000,000 IU — Novartis Nigeria Limited — Withdrawn voluntarily.
Salbutamol 100mcg Inhaler — Inhaler — NAFDAC B4-8493 — Salbutamol 100mcg — Novartis Nigeria Limited — Withdrawn voluntarily.
Sporanox (Itraconazole) 100mg capsule — Capsule — NAFDAC 04 2404 — Itraconazole 100mg — Worldwide Healthcare Ventures Limited — Withdrawn voluntarily.
Xyzal Oral Drops — Drops — NAFDAC B4-9691 — Levocetirizine Dihydrochloride — GlaxoSmithKline Pharmaceutical Nigeria Ltd — Withdrawn voluntarily.
Zidovudine 300mg Tablets — Tablets — NAFDAC A4-1314 — Zidovudine 300mg — Healthline Limited — Withdrawn voluntarily.
Uptivite Man Tablets — Supplement — NAFDAC A7-101014L — (unspecified) — Gentlehills Limited — Cancelled by NAFDAC.
Mist Alba Suspension — Suspension — NAFDAC A11-0871 — Magnesium Sulphate — Gentlehills Limited — Cancelled by NAFDAC.
Gentle Hill Cough Syrup — Syrup — NAFDAC A11-0872 — Diphenhydramine HCl, Ammonium Chloride, Menthol, Sodium Citrate — Gentlehills Limited — Cancelled by NAFDAC.
Gentlehills Vitamin C Syrup — Syrup — NAFDAC A11-0936 — Ascorbic Acid — Gentlehills Limited — Cancelled by NAFDAC.
Mycobutin 150mg caps — Capsules — NAFDAC A4-4726 — Rifabutin 150mg — Pfizer Specialties Limited — Withdrawn voluntarily.
Neo-Medrol Lotion — Lotion — NAFDAC 04-3778 — Methylprednisolone Acetate 2.5mg / Neomycin sulphate 2.5mg — Pfizer Specialties Limited — Withdrawn voluntarily.
Fortum Injection (Powder for injection) — Powder for injection — NAFDAC 04-2249 — Ceftazidime 1g (as pentahydrate) — GlaxoSmithKline Pharmaceutical Nigeria Ltd — Withdrawn voluntarily.
Proximexa Injection (Powder for injection) — Powder for injection — NAFDAC A4-5555 — Cefuroxime Axetil 500mg — GlaxoSmithKline Pharmaceutical Nigeria Ltd — Withdrawn voluntarily.
Diclo-Neurobion tablets — Tablets — NAFDAC A4-1231 — Diclofenac sodium 50mg; Vitamins B1 50mg, B6 50mg, B12 0.25mg — Fensyl MHP Consulting Ltd — Withdrawn voluntarily.
Artemether 80mg/Lumefantrine 480mg tablets — Tablets — NAFDAC A4-5641 — Artemether/Lumefantrine 80/480 — Lyn-Edge Pharmaceuticals Limited — Withdrawn voluntarily.
Fortum Injection 1g — Injectables — NAFDAC 04-2249 — Ceftazidime pentahydrate — GlaxoSmithKline Pharmaceutical Nigeria Ltd — Withdrawn voluntarily.
Proximexa 500mg — (listed under injectables/tablets) — NAFDAC A4-5555 — Cefuroxime Axetil — GlaxoSmithKline Pharmaceutical Nigeria Ltd — Withdrawn voluntarily.
Mosegor Tablet — Tablet — NAFDAC 04 8106 — Pizotifen 0.05mg — Novartis — Withdrawn voluntarily.
Lexotan 3mg Tablet — Tablet — NAFDAC 04-8808 — Bromazepam — F. Hoffmann-La Roche Ltd — Withdrawn voluntarily.
Norditropin Nordiflex — Injectables — NAFDAC A6-100010 — Somatropin — Novo Nordisk Pharma — Withdrawn voluntarily.
Norditropin Nordiflex (second listing / pack size) — Injectables — NAFDAC A6-100011 — Somatropin — Novo Nordisk Pharma — Withdrawn voluntarily.
Saxenda — Injectables — NAFDAC A6-100004 — Liraglutide 6.0 mg — Novo Nordisk Pharma — Withdrawn voluntarily.
Artemether Lumefantrine 80/480 Tablets — Tablet — NAFDAC A4-101026 — Artemether/Lumefantrine — Fredun Pharmaceuticals Ltd — Withdrawn voluntarily.
Cryomarex Rispens HVT Vaccine — Vaccine — NAFDAC A6-0066 — Attenuated Marek’s Disease Virus, Ripens Strain 1000 PFU — Fensyl MHP Consulting Ltd — Withdrawn voluntarily.
Letrozole 2.5mg Tablet — Tablet — NAFDAC B4-7680 — Letrozole 2.5mg — Novartis — Withdrawn voluntarily.
Zometa intravenous infusion — Infusion — NAFDAC A4-5636 — Zoledronic acid monohydrate — Novartis — Withdrawn voluntarily.
Valsartan 80mg Tablet — Tablet — NAFDAC B4-7777 — Valsartan — Novartis — Withdrawn voluntarily.
Valsartan 160mg Tablet — Tablet — NAFDAC B4-7682 — Valsartan — Novartis — Withdrawn voluntarily.
Valsartan 50mg Tablet — Tablet — NAFDAC B4-7681 — Valsartan — Novartis — Withdrawn voluntarily.
Prezista 75mg Tablet — Tablet — NAFDAC B4-7649 — Darunavir (dosage listing indicates 600mg elsewhere) — Blooms Pharmaceutical Ltd — Withdrawn voluntarily.
Prezista 150mg Tablet — Tablet — NAFDAC B4-7650 — Darunavir — Blooms Pharmaceutical Ltd — Withdrawn voluntarily.
Prezista 600mg Tablet — Tablet — NAFDAC A4-7676 — Darunavir — Blooms Pharmaceutical Ltd — Withdrawn voluntarily.
Intelence 25mg Tablet — Tablet — NAFDAC A4-100493 — Etravirine — Blooms Pharmaceutical Ltd — Withdrawn voluntarily.
Intelence 100mg Tablet — Tablet — NAFDAC A4-8886 — Etravirine — Blooms Pharmaceutical Ltd — Withdrawn voluntarily.
Abacavir Sulfate/Lamivudine Tablets for oral suspension 120mg/60mg — Tablet (for suspension) — NAFDAC B4-8619 — Abacavir Sulfate/Lamivudine — Cipla — Withdrawn voluntarily.
Daktarin 2% 1x15g cream — Cream — NAFDAC 04-1589 — Miconazole nitrate — Johnson & Johnson — Withdrawn voluntarily.
Coveram 10mg/10mg Tablets — Tablet — NAFDAC A4-6817 — Perindopril 10mg / Amlodipine 10mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Coveram 10mg/5mg Tablets — Tablet — NAFDAC A4-6818 — Perindopril 10mg / Amlodipine 5mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Coveram 5mg/10mg Tablets — Tablet — NAFDAC A4-6816 — Perindopril 5mg / Amlodipine 10mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Coveram 5mg/5mg Tablets — Tablet — NAFDAC A4-6819 — Perindopril 5mg / Amlodipine 5mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Coversyl 5mg Tablets — Tablet — NAFDAC A4-5001 — Perindopril 5mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Coversyl 10mg Tablets — Tablet — NAFDAC A4-5030 — Perindopril 10mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Coversyl plus 10mg/2.5mg Tablets — Tablet — NAFDAC B4-4158 — Perindopril 10mg / Indapamide 2.5mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Coversyl Plus 5mg/1.25mg Tablets — Tablet — NAFDAC B4-4159 — Perindopril 5mg / Indapamide 1.25mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Natrilix SR 1.5mg Tablets — Tablet — NAFDAC 04-4159 — Indapamide SR 1.5mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Vastarel MR 60mg Tablet — Tablet — NAFDAC B4-1945 — Trimetazidine dihydrochloride MR — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Diamicron MR 30mg Tablets — Tablet — NAFDAC B4-9083 — Gliclazide MR 30mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Diamicron MR 60mg Tablet — Tablet — NAFDAC A4-7426 — Gliclazide MR 60mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Daflon 1000mg Tablet — Tablet — NAFDAC A7-4942L — Micronized Purified Flavonoid Fraction — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Daflon 500mg Tablet — Tablet — NAFDAC 04-6857 — Micronized Purified Flavonoid Fraction — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Triveram 10mg/5mg/5mg Tablet — Tablet — NAFDAC C4-1735 — Atorvastatin 10mg / Perindopril 5mg / Amlodipine 5mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Triveram 20mg/5mg/5mg Tablet — Tablet — NAFDAC C4-1736 — Atorvastatin 20mg / Perindopril 5mg / Amlodipine 5mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Triveram 20mg/10mg/5mg Tablet — Tablet — NAFDAC C4-1737 — Atorvastatin 20mg / Perindopril 10mg / Amlodipine 5mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Triveram 20mg/10mg/10mg Tablet — Tablet — NAFDAC C4-1738 — Atorvastatin 20mg / Perindopril 10mg / Amlodipine 10mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Triveram 40mg/10mg/10mg Tablet — Tablet — NAFDAC C4-1739 — Atorvastatin 40mg / Perindopril 10mg / Amlodipine 10mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Viacoram 3.5mg/2.5mg Tablet — Tablet — NAFDAC C4-0375 — Perindopril 3.5mg / Amlodipine 2.5mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Viacoram 7mg/5mg Tablet — Tablet — NAFDAC C4-0376 — Perindopril 7mg / Amlodipine 5mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Natrixam 1.5mg/5mg Tablet — Tablet — NAFDAC B4-4153 — Indapamide 1.5mg / Amlodipine 5mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Natrixam 1.5mg/10mg Tablet — Tablet — NAFDAC B4-4152 — Indapamide 1.5mg / Amlodipine 10mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Coveram Plus 5mg/1.25mg/5mg Tablet — Tablet — NAFDAC B4-6499 — Perindopril 5mg / Indapamide 1.25mg / Amlodipine 5mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Coveram Plus 5mg/1.25mg/10mg Tablet — Tablet — NAFDAC B4-6500 — Perindopril 5mg / Indapamide 1.25mg / Amlodipine 10mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Coveram Plus 10mg/1.25mg/5mg Tablet — Tablet — NAFDAC B4-6497 — Perindopril 10mg / Indapamide 1.25mg / Amlodipine 5mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Coveram Plus 10mg/1.25mg/10mg Tablet — Tablet — NAFDAC B4-6498 — Perindopril 10mg / Indapamide 1.25mg / Amlodipine 10mg — Servier Pharmaceuticals Development Ltd — Withdrawn voluntarily.
Braftovi 50mg Capsules — Capsules — NAFDAC A4-100330 — Encorafenib 50mg — Pfizer Specialties Limited — Withdrawn voluntarily.
Braftovi 75mg Capsules — Capsules — NAFDAC A4-100331 — Encorafenib 75mg — Pfizer Specialties Limited — Withdrawn voluntarily.
Mektovi 15mg Tablets — Tablets — NAFDAC A4-100332 — Binimetinib 15mg — Pfizer Specialties Limited — Withdrawn voluntarily.
