NAFDAC orders nationwide mop-up of Europharm products over low API content, quality failures

The National Agency for Food and Drug Administration and Control (NAFDAC) has ordered a nationwide mop-up of all Europharm Laboratories products after laboratory tests revealed low active pharmaceutical ingredient levels and other serious quality failures in several formulations produced by the company.

The agency announced the directive in a public warning issued through its official X handle, stating that enforcement teams had already begun removing the affected medicines from circulation across the country.
According to NAFDAC, the mop-up follows credible intelligence and regulatory surveillance, indicating that Europharm Laboratories had been producing, selling, and distributing multiple pharmaceutical and regulated products without the required marketing authorisation. Investigators reportedly found numerous items at the company’s facility that were being manufactured or circulated in violation of national drug safety regulations.

The agency said laboratory analysis confirmed significant quality defects in some of the products, raising major public health concerns. Tests conducted on two formulations of Linmoxyn (Amoxicillin) showed critically low API levels. The suspension version failed with 13.9 per cent and 18.4 per cent API content, while the 500mg capsules recorded only 48.3 per cent, confirming them to be grossly substandard.
NAFDAC added that several products bearing different registration numbers were recovered from the Europharm Laboratories site in Jos. Among them were Linocloxin, Linromycine, Linocillin, Linmoxyn suspension, Eurogyl, Naflin, Natacid, Navit-B, Fountain B-12 syrups, Vitamin-C syrup, Eurogyl tablets, Euramol tablets, Euramox tablets, Linotrim and Linoquine.

The agency urged distributors, retailers, health professionals, and caregivers to remain vigilant along the supply chain and to avoid stocking or dispensing any unverified products. It emphasised that medicines should only be purchased from authorised or licensed suppliers and that users must carefully check the authenticity and physical condition of products before use.
NAFDAC called on healthcare workers and members of the public to immediately report any suspicion of substandard or falsified medical products to the nearest NAFDAC office, or through its toll-free line.
Meanwhile, NAFDAC has urged operators across multiple sectors to adhere strictly to its regulatory requirements, warning that failure to comply could attract legal sanctions. The warning was issued by the South-East Zonal Director, Dr Festus Ukadike, during a one-day stakeholders’ sensitisation programme held in Owerri, Imo State.

The meeting brought together representatives from the National Association of Patent and Proprietary Medicines (NAPPMED), the Association of Table Water Producers (ATWAP), Association of Community Pharmacists of Nigeria (ACPN), Association of Supermarket Operators, National Association of Industrial Pharmacists (NAIP), agro-input dealers, herbal medicine practitioners, bakers, and food outlets including Chicken Republic.
Dr. Ukadike emphasised the agency’s mandate to safeguard public health, stating, “NAFDAC has the mandate to ensure that all regulatory products meet the standards of quality, safety and efficacy. Our shared mandate is to do everything within our powers to protect public health. Ours is that of a regulator — to make sure you comply with all the guidelines made available to you in the discharge of your responsibilities.”

He urged stakeholders to maintain good hygiene and manufacturing practices, ensure that registration licences are valid, and keep personnel, procedures, and equipment aligned with regulatory guidelines. Dr. Ukadike also highlighted the importance of proper storage and distribution, warning against unscientific claims that a single drug could cure multiple ailments such as hypertension, diabetes, and asthma.

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