The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the immediate withdrawal, suspension, and cancellation of 101 pharmaceutical products from the Nigerian market. The agency explicitly stated that these products are no longer permitted for manufacture, importation, exportation, distribution, advertisement, sale, or use within the country.
Extensive List Covers Major Health Categories
The action, disclosed by NAFDAC on its official X handle on Tuesday, September 30, 2025, covers a wide range of essential medicines and health products, affecting hundreds of formulations.
The withdrawn products span critical treatment areas, including:
- Antimalarials: Various artemether/lumefantrine and artesunate/amodiaquine (ASAQ) formulations (e.g., ASAQ Winthrop tablets).
- Cardiovascular Drugs: Products containing Amlodipine and Valsartan (e.g., Aprovasc tablets).
- Diabetes and Hormones: Medicines like Januvia/Janumet and injectables such as Norditropin (insulin/growth-hormone).
- Other Essential Medicines: Including Abacavir tablets, Amaryl tablets, and various inhalers and eye drops.
The pharmaceutical companies affected are well-known entities, including Sanofi Aventis Nigeria Ltd, Novartis Nigeria Limited, Bayer East Africa Limited, Healthline Limited, and Fensyl MHP Consulting Ltd, among others. The complete list of all 101 products is available on the NAFDAC website.
The Distinction Between Withdrawal, Suspension, and Cancellation
NAFDAC provided clarity on the different regulatory actions taken against the products:
- Withdrawal: Occurs when the Certificate of Registration is discontinued upon the request of the Market Authorization Holder (the product owner).
- Suspension: Imposed when the conditions upon which the NAFDAC Registration license was issued are no longer met, pending a determination by the Agency.
- Cancellation: Occurs when the NAFDAC Certificate of Registration license of the product is revoked by the Agency.
NAFDAC’s Action Amid Global Quality Concerns
This decisive action by NAFDAC comes amidst intensified global concerns regarding the menace of fake and substandard medicines. Substandard and falsified medical products pose a major global health risk, impacting health systems and affecting life-saving treatments like antibiotics and vaccines worldwide.
The World Health Organization (WHO) previously estimated that as many as 1 in 10 medicines in low- and middle-income countries fail quality control tests. In response to this persistent challenge, NAFDAC recently sought the enhanced collaboration of pharmacists to help tackle the issue of substandard and falsified medicines across the country.
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