NAFDAC Withdraws, Suspends, Cancels Approval for multiple Medicine Products [Full List]

The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the withdrawal, suspension, and cancellation of approval for several pharmaceutical products.

In statement obtained by iDeemlawful, it reads that;

‘This is to inform the General Public that the following list of products are approved for withdrawal, suspension and cancellation by NAFDAC.

‘They are therefore no longer permitted for manufacture, importation, exportation, distribution, advertisement, sale and use within Nigeria.

This decision, shared via a post on X, affects the manufacture, importation, exportation, distribution, advertisement, sale, and use of these products within Nigeria.

List of Withdrawn Products:

• Abacavir Sulfate/Lamivudine Dispersible Tablets 60mg/30mg Tablets – NAFDAC Number: C4-1180. Active Ingredient: Abacavir sulfate and Lamivudine. Market Authorization Holder: Healthline Limited.
• Amaryl M Tablets – NAFDAC Number: A4-2619. Active Ingredient: Glimepiride + Metformin Hydrochloride. Market Authorization Holder: Sanofi Aventis Nigeria Ltd.
• Amaryl M SR Tablets – NAFDAC Number: A4-7296. Active Ingredient: Glimepiride + Metformin Hydrochloride. Market Authorization Holder: Sanofi Aventis Nigeria Ltd.
• Aprovasc 150mg/5mg Tablets – NAFDAC Number: B4-2687. Active Ingredient: Amlodipine Besylate + Aprovasc. Market Authorization Holder: Sanofi Aventis Nigeria Ltd.
• Artemether/Lumefantrine 40mg/240mg Tablets – NAFDAC Number: B4-5745. Active Ingredient: Artemether/Lumefantrine 40mg/240mg. Market Authorization Holder: Healthline Limited.
• ASAQ (Artesunate Amodiaquine Winthrop) 100mg/270mg Tablets – NAFDAC Number: A4-3357. Active Ingredient: Artesunate Amodiaquine Winthrop 100mg/270mg. Market Authorization Holder: Sanofi Aventis Nigeria Ltd.
• ASAQ (Artesunate Amodiaquine Winthrop) 25mg/67.5mg Tablets – NAFDAC Number: A4-3406. Active Ingredient: Artesunate Amodiaquine Winthrop 25mg/67.5mg. Market Authorization Holder: Sanofi Aventis Nigeria Ltd.
• ASAQ (Artesunate Amodiaquine Winthrop) 50mg/135mg Tablets – NAFDAC Number: A4-3405. Active Ingredient: Artesunate Amodiaquine Winthrop 50mg/135mg. Market Authorization Holder: Sanofi Aventis Nigeria Ltd.
• Betopic Eye Drop – NAFDAC Number: 04 2404. Active Ingredient: Batexolol Hydrochloride. Market Authorization Holder: Novartis.
• Coaprovel 300mg/25mg Tablets – NAFDAC Number: B4-2317. Active Ingredient: Hydrochlorothiazide + Irbesartan. Market Authorization Holder: Sanofi Aventis Nigeria Ltd.
• Combination 3 Tablets – NAFDAC Number: A4-6459. Active Ingredient: Estrogen, Progestin. Market Authorization Holder: Bayer East Africa Limited.
• Efavirenz 600mg Tablets – NAFDAC Number: A4-1318. Active Ingredient: Efavirenz 600mg. Market Authorization Holder: Healthline Limited.
• Elisca Eye Drop – NAFDAC Number: 04 2461. Active Ingredient: Chloramphenicol Eye Drop. Market Authorization Holder: Sanofi Aventis Nigeria Ltd.
• Flagyl Suspension – NAFDAC Number: A4-3947. Active Ingredient: Metronidazole Benzoate. Market Authorization Holder: Sanofi Aventis Nigeria Ltd.
• Flagyl Tablet 400mg – NAFDAC Number: 04 5566. Active Ingredient: Metronidazole. Market Authorization Holder: Sanofi Aventis Nigeria Ltd.
• Iliadin Adult 0.05% Metered Nose Spray – NAFDAC Number: B4-9913. Active Ingredient: Oxymetazoline HCl 0.05%M/V. Market Authorization Holder: Fensyl MHP Consulting Ltd.
• Iliadin Baby 0.01% Nose Drops – NAFDAC Number: C4-0106. Active Ingredient: Oxymetazoline HCl 0.01%M/V. Market Authorization Holder: Fensyl MHP Consulting Ltd.
• Iliadin Kids 0.025% Nose Drops – NAFDAC Number: B4-9912. Active Ingredient: Oxymetazoline HCl 0.025%M/V. Market Authorization Holder: Fensyl MHP Consulting Ltd.
• Invanz 1g Injections – NAFDAC Number: 04 8118. Active Ingredient: Ertapenem 1g. Market Authorization Holder: MSD Idea Pharmaceuticals Nigeria Ltd.
• Invega (Paliperidone) 3mg Extended Release Tablets – NAFDAC Number: B4-8223. Active Ingredient: Paliperidone. Market Authorization Holder: Janssen Pharmaceutical Companies.

NAFDAC advises the public to discontinue the use, sale, and distribution of these products.

The agency emphasizes the importance of ensuring that only approved and safe medications are available in the market to protect public health