NAFDAC ISSUES PUBLIC ALERT ON SUBSTANDARD AND FALSIFIED ARTEMETRIN DS AND CIPROFIT 500 MALARIA DRUGS IN NIGERIA.

By Prince Uwalaka Chimaroke
17- SEPT- 2025

The National Agency for Food and Drug Administration and Control (NAFDAC) has raised a serious public health warning following the confirmation of substandard and falsified medicines currently in circulation in Nigeria. The alert, issued under Public Alert No. 030/2025, pertains specifically to two products: ARTEMETRIN DS (Artemether/Lumefantrine) 80mg/480mg tablets and CIPROFIT 500 (Ciprofloxacin Tablet USP 500mg).

According to NAFDAC, the falsified ARTEMETRIN DS tablets are labelled as manufactured by A.C. Drugs Ltd, Plot C5/C6 Old Airport Road, Emene-Enugu State, Nigeria, while the falsified CIPROFIT 500 tablets are labelled as manufactured by Impact Pharmaceutical Ltd, No. 33A/33B Standard Industrial Layout, Emene-Enugu State, Nigeria. Both manufacturers’ details are fictitious, and the products do not appear in the NAFDAC registered products database. Furthermore, the registration numbers displayed on the packaging are false.

The Agency explained that initial testing of the products through Thin-Layer Chromatography (TLC) revealed irregularities, which prompted further investigations. Comprehensive testing was subsequently conducted at a World Health Organization (WHO)-prequalified laboratory using High-Performance Liquid Chromatography (HPLC) assay. The results confirmed that both medicines were grossly substandard:

ARTEMETRIN DS (Artemether/Lumefantrine) contained only 59.2% Artemether and 71.2% Lumefantrine, which fall well below the acceptable pharmacological range of 90-110%.

CIPROFIT 500 (Ciprofloxacin USP 500mg) contained only 5.7% Ciprofloxacin, a dangerously low concentration that renders the medicine ineffective and potentially harmful.

NAFDAC emphasized the dangers posed by these falsified products, warning that consumption could lead to treatment failure, worsening of disease conditions, antimicrobial resistance, and even loss of life. Particularly, the ineffective levels of active ingredients in these medicines compromise the health of patients who rely on them for the treatment of malaria and bacterial infections.

The Agency disclosed that these products were purchased from a “licensed vendor and wholesaler”, thereby highlighting the fact that even legitimate distribution channels can unknowingly circulate falsified medicines.

NAFDAC strongly advised members of the public to immediately discontinue the sale or use of these products. Individuals or vendors in possession of ARTEMETRIN DS or CIPROFIT 500 are instructed to return their stock to the nearest NAFDAC office without delay.

Furthermore, anyone who has consumed these medicines and experienced adverse reactions is urged to seek urgent medical attention from qualified healthcare professionals. Healthcare workers and consumers are equally encouraged to be vigilant and to report any suspected cases of substandard or falsified medicines directly to NAFDAC through the following channels:

Nearest NAFDAC office
Toll-free number: 0800-162-3322
Email: sf.alert@nafdac.gov.ng

This latest alert reinforces NAFDAC’s commitment to safeguarding public health through the surveillance, detection, and elimination of dangerous and falsified medical products in the Nigerian market. The Agency reiterated that it will continue working in collaboration with local and international partners to protect citizens from the grave risks posed by counterfeit medicines.