The National Agency for Food and Drugs Administration and Control (NAFDAC) has alerted healthcare providers and the general public of the nationwide mop-up of products by Europharm Laboratories in Jos.
The agency, via its X handle on Friday, said it started the enforcement against Europharm Laboratories and Eurolink Nigeria Ltd., located at Plot Pl., 7354, Anglo Jos, New Ind. Area, following credible intelligence and regulatory surveillance.
It said investigations revealed that the company had been producing, selling, and distributing multiple pharmaceutical and other regulated products without the necessary marketing authorisation (MA).
According to NAFDAC, several products were discovered at the facility, many of which were being produced or distributed in violation of NAFDAC regulations during the investigation.
It noted that laboratory analysis was conducted on some of the products, which further confirmed significant quality failures, raising serious public health concerns.
It revealed that the results of the analysis showed low Active Pharmaceutical Ingredients (API) content for Linmoxyn (Amoxicillin) suspension and Linmoxyn (Amoxicillin 500mg capsules) with the following outcome:
It said Linmoxyn (amoxicillin suspension) failed analysis with API content of 13.9% and 18.4%, which is far below acceptable limits, while Linmoxyn (amoxicillin 500 mg capsules) also failed, with API content of only 48.3 per cent, confirming it to be grossly substandard.
It said other products bearing various NAFDAC registration numbers (NRNs) were found at the Europharm Laboratories site during the investigation.
NAFDAC explained that the risk of low API in medicines included treatment failure, antimicrobial resistance, and potential safety concerns to consumers.
It said the products included Linocloxin (Ampicillin 125mg & Cloxacillin 125mg) powder for oral suspension 100ml, Linromycine (Erythromycin) powder for suspension 100ml, Linocillin (Ampicillin) powder for oral suspension 50ml and Linmoxyn (Amoxicillin 125mg) suspension 60ml.
The others 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, and Fountain B-12 (Blood Tonic) 100 ml and 200 ml.
It also included Vitamin-C Syrup 100ml, Eurogyl (Metronidazole) Tablet blister 10×10 tabs, Eurogyl (Metronidazole) x1000 tablets, Euramol (Paracetamol) x1000 tablets, Euramox (Mebendazole 100mg) tablets, Linotrim (Cotrimoxazole suspension) 50ml and Linoquine (Chloroquine Phosphate syrup 80mg/5ml) 60ml.
NAFDAC said all zonal directors and state coordinators had been directed to carry out surveillance and mop up the substandard products within the zones and states.
It urged all distributors, retailers, healthcare professionals and caregivers to exercise caution and vigilance within the supply chain to avoid the distribution, sale and use of the substandard products.
It also advised healthcare professionals and consumers to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office.
(NAN)
