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Control (NAFDAC) has issued a clarification to help Nigerians understand its recent publication on a list of 101 drug withdrawn, suspended, and cancelled by the agency.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 Mojisola Adeyeye, NAFDAC’s Director-General, the clarification explains the meanings of the three key classifications withdrawn, suspended, and cancelled and their implications for the public and manufacturers.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NAFDAC emphasized that publishing lists of withdrawn, suspended, or cancelled products is a global best practice intended to prevent counterfeit circulation and ensure unsafe or discontinued medicines do not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.
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For antimalarials, Artemether/Lumefantrine and ASAQ tablets were withdrawn voluntarily by their manufacturers for commercial reasons.
In the antimicrobial category, Penicillin G Sodium Sandoz Powder (1,000,000 IU) was also withdrawn voluntarily by Novartis Nigeria Ltd, while Elisa Eye Drops (Chloramphenicol) had its approval revoked due to regulatory action.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diabetes drug category, Januvia (50mg & 100mg), Janumet (50mg/850mg), and Amaryl M Tablets (1mg, 2mg, and 4mg SR) were withdrawn from the market. Other withdrawn medicines include Aprovasc (150mg/5mg), Coaprovel (300mg/25mg), and Abacavir Sulfate/Lamivudine (60mg/30mg) tablets.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
NAFDAC has intensified its nationwide crackdown on counterfeit and expired medical products, conducting multiple high-profile operations
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.