NAFDAC clarifies withdrawal of 101 drugs in Nigeria

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a clarification to help Nigerians understand its recent publication on a list of 101 drug withdrawn, suspended, and cancelled by the agency.

The agency said the move was necessary to provide clarity on the regulatory status of affected products and to protect public health.

According to a statement signed by Prof. Mojisola Adeyeye, NAFDAC’s Director-General, the clarification explains the meanings of the three key classifications withdrawn, suspended, and cancelled and their implications for the public and manufacturers.

NAFDAC explains product classifications  

• NAFDAC explained that withdrawn refers to when a company voluntarily discontinues a product, usually for commercial or market reasons, not necessarily due to safety or quality concerns. For example, products like Artemether/Lumefantrine 40mg/240mg tablets by Healthline Limited and ASAQ (Artesunate Amodiaquine Winthrop) tablets by Sanofi Aventis Nigeria Ltd were voluntarily withdrawn for business-related reasons.
• The suspended status, according to NAFDAC, applies when the agency temporarily halts a product’s registration due to non-compliance with regulatory standards. Such cases remain under review until the manufacturer takes corrective actions to meet compliance requirements.
• Products classified as cancelled have had their registration completely revoked, meaning they are no longer approved for manufacture, importation, sale, or use in Nigeria. These cancellations often follow issues related to product safety, poor manufacturing practices, or quality control failures.

NAFDAC emphasized that publishing lists of withdrawn, suspended, or cancelled products is a global best practice intended to prevent counterfeit circulation and ensure unsafe or discontinued medicines do not remain on the market.

Key examples of affected products 

Among the affected medicines, several well-known brands were included. NAFDAC listed Flagyl Suspension and Tablets (400mg) as no longer approved for use or sale, although other Metronidazole formulations remain registered.

For antimalarials, Artemether/Lumefantrine and ASAQ tablets were withdrawn voluntarily by their manufacturers for commercial reasons.

In the antimicrobial category, Penicillin G Sodium Sandoz Powder (1,000,000 IU) was also withdrawn voluntarily by Novartis Nigeria Ltd, while Elisa Eye Drops (Chloramphenicol) had its approval revoked due to regulatory action.

In the diabetes drug category, Januvia (50mg & 100mg), Janumet (50mg/850mg), and Amaryl M Tablets (1mg, 2mg, and 4mg SR) were withdrawn from the market. Other withdrawn medicines include Aprovasc (150mg/5mg), Coaprovel (300mg/25mg), and Abacavir Sulfate/Lamivudine (60mg/30mg) tablets.

The list also featured Norditropin Growth Hormone Injectables and Insulin Injectables, which have both been delisted following regulatory reviews, as well as Cryomarex Rispens HVT Vaccine, which was removed due to regulatory actions.

For full details of the 101 products affected click here

More details 

NAFDAC has intensified its nationwide crackdown on counterfeit and expired medical products, conducting multiple high-profile operations

• In October,the agency destroyed counterfeit, expired, controlled, and banned drugs worth more than N15 billion in Ibadan, Oyo State. The items included Analgin, Co-codamol, codeine cough syrups, Tramadol, Oxytocin, and expired vaccines. One of the most notable seizures involved a container falsely labelled as diclofenac but packed with anti-malaria drugs,277 cartons containing over 100,000 tablets.
• A month earlier, the agency uncovered another major operation in Lagos, where officials seized unregistered Malamal Forte malaria medicines worth N1.2 billion from a warehouse in Ilasa-Oshodi. The products had been concealed in cartons marked as Diclofenac Potassium.

At Lagos’s Trade Fair market, NAFDAC confiscated banned, expired, and unregistered goods, particularly cosmetics, worth over N1.5 billion. Some of these products were imported illegally or had bypassed safety and quality testing, while an entire truckload of fake goods was also intercepted.

NAFDAC clarifies withdrawal of 101 drugs in Nigeria - Nairametrics