Lagos, Nigeria – Nigeria’s drug regulator, the National Agency for Food and Drug Administration and Control (NAFDAC), orders an immediate nationwide mop-up of all pharmaceutical products manufactured by EuroPharm Laboratories, citing serious quality failures and regulatory breaches.
In a public notice issued on Friday, NAFDAC says enforcement action follows “credible intelligence and regulatory surveillance” indicating that the company produces and distributes medicines without valid marketing authorisation.
The agency says investigations at the Europharm facility uncover multiple products manufactured in violation of existing regulations, with laboratory tests confirming “significant quality failures.”
NAFDAC highlights Linmoxyn (Amoxicillin) as a key concern. According to the agency, the oral suspension fails analysis with API content of 13.9% and 18.4%, while the 500mg capsules record only 48.3%, far below acceptable standards.
“These levels are grossly substandard and pose serious public health risks,” the agency warns.
Other affected products include Linocloxin, Linromycine, Linocillin, Eurogyl, Naflin, Navit-B Syrup, Fountain B-12, Euramol, Euramox, Linotrim and Linoquine, among several others bearing different NAFDAC registration numbers.
All listed products are now subject to an immediate nationwide recall.
NAFDAC urges distributors, retailers, healthcare providers and caregivers to exercise “heightened vigilance” across the supply chain and stop circulation of the affected medicines.
The agency advises Nigerians to purchase medicines only from authorised sources and to report suspected substandard products via its toll-free line 0800-162-3322 or email sf.alert@nafdac.gov.ng.
