NAFDAC has announced the withdrawal, suspension, and cancellation of several pharmaceutical products in Nigeria, prohibiting their manufacture, importation, sale, and useThe affected products include Abacavir Sulfate/Lamivudine, Amaryl M, and Flagyl, among others, due to various reasons provided by their market authorization holdersThe agency urges the public to discontinue use and distribution of these products to ensure safety and compliance
The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the withdrawal, suspension, and cancellation of approval for several pharmaceutical products.
This decision, shared via a post on X, affects the manufacture, importation, exportation, distribution, advertisement, sale, and use of these products within Nigeria.
NAFDAC withdraws many products. Photo credit: X/NafdacNig
Source: Twitter
List of Withdrawn Products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.
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Advisory to the Public
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.
NAFDAC Deregisters, Bans Popular Beauty Soap
Meanwhile, Henzodaily.ng earlier reported that the National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert regarding the recall of Dove Beauty Cream Bar Soap (100g) with batch number 81832M 08.
The product, manufactured in Germany, has been found to contain Butylphenyl Methylpropional (BMHCA), a chemical impurity that poses significant health risks.
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Source: Henzodaily.ng