NAFDAC Orders Nationwide Mop-Up of Substandard Drugs Linked to Europharm Laboratories

NAFDAC Orders Nationwide Mop-Up of Substandard Drugs Linked to Europharm Laboratories
It urged all distributors, retailers, healthcare professionals and caregivers to exercise caution.
Warns that medicines with low API content pose serious risks

The National Agency for Food and Drugs Administration and Control, NAFDAC, has commenced a nationwide mop-up of pharmaceutical products manufactured by Europharm Laboratories in Jos following the discovery of widespread regulatory violations and quality failures.

Contents

EDITOR’S PICK
FURTHER READING

Eko Hot Blog reports that the agency disclosed the development in a statement posted on its official X handle on Friday, saying enforcement actions were initiated against Europharm Laboratories and Eurolink Nigeria Ltd., located at Plot Pl. 7354, Anglo Jos New Industrial Area, Plateau State, after credible intelligence and regulatory surveillance.

EDITOR’S PICK

NAFDAC said investigations revealed that the company had been producing, selling, and distributing several pharmaceutical and other regulated products without valid marketing authorisation.

According to the agency, multiple products were discovered at the facility during the investigation, many of which were manufactured or distributed in breach of NAFDAC regulations.

Laboratory analysis conducted on some of the products confirmed significant quality failures, raising serious public health concerns. NAFDAC said the tests revealed dangerously low Active Pharmaceutical Ingredient, API, levels in key antibiotic products.

Linmoxyn (Amoxicillin) suspension failed analysis with API contents of 13.9% and 18.4%, far below acceptable limits, while Linmoxyn (Amoxicillin 500 mg capsules) recorded an API content of only 48.3%, confirming the product to be grossly substandard.

The agency also discovered other products bearing various NAFDAC Registration Numbers, NRNs, at the Europharm Laboratories site during the operation.

NAFDAC Orders Nationwide Mop-Up of Substandard Drugs Linked to Europharm Laboratories

NAFDAC warned that medicines with low API content pose serious risks, including treatment failure, antimicrobial resistance, and potential safety hazards to consumers.

The affected products include Linocloxin (Ampicillin 125 mg and Cloxacillin 125 mg) powder for oral suspension 100 ml, Linromycine (Erythromycin) powder for suspension 100 ml, Linocillin (Ampicillin) powder for oral suspension 50 ml, and Linmoxyn (Amoxicillin 125 mg) suspension 60 ml.

Other listed products are Eurogyl (Metronidazole suspension) 50 ml, Naflin (Cough Expectorant) 100 ml, Natacid (Magnesium Trisilicate suspension) 100 ml, Navit-B Syrup (Vitamin B Complex) 100 ml, Fountain B-12 Blood Tonic 100 ml and 200 ml, and Vitamin-C Syrup 100 ml.

Also included are Eurogyl (Metronidazole) tablets in blister packs of 10×10 tablets, Eurogyl (Metronidazole) 1000 tablets, Euramol (Paracetamol) 1000 tablets, Euramox (Mebendazole 100 mg) tablets, Linotrim (Cotrimoxazole suspension) 50 ml, and Linoquine (Chloroquine Phosphate syrup 80 mg/5 ml) 60 ml.

NAFDAC said all zonal directors and state coordinators nationwide have been directed to intensify surveillance and ensure the immediate mop-up of the affected products.

The agency urged distributors, retailers, healthcare professionals, and caregivers to exercise caution and vigilance within the supply chain to prevent the sale and use of substandard medicines.

It also advised healthcare professionals and consumers to promptly report any suspected sale of substandard or falsified medicines and medical devices to the nearest NAFDAC office.