The National Agency for Food and Drug Administration and Control (NAFDAC) has raised the alarm over the authorised marketing and sale of pharmaceutical products by a private firm.
The agency said it had carried out a nationwide mop-up of “all products produced and distributed by EUROPHARM LABORATORIES”.
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NAFDAC explained that it commenced the enforcement actions “against Europharm Laboratories following credible intelligence and regulatory surveillance indicating that the company has been producing, selling, and distributing multiple pharmaceutical and other regulated products without the necessary marketing authorisation (MA)”.
“During the investigation, several products were discovered at the facility, many of which were being produced or distributed in violation of NAFDAC regulations.
“Laboratory analysis carried out on some of the products further confirmed significant quality failures, raising serious public health concerns,” NAFDAC stated in a post on its official X handle on Friday.
It stated that the result of the analysis showed low API content for Linmoxyn (Amoxicillin) suspension and Linmoxyn (Amoxicillin 500mg capsules), with the following outcome: Linmoxyn (Amoxicillin suspension) failed analysis with API content of 13.9 per cent and 18.4 per cent (far below acceptable limits).
“Linmoxyn (Amoxicillin 500mg capsules) also failed, with API content of only 48.3 per cent, confirming it to be grossly substandard,” NAFDAC said.
The agency further disclosed that products bearing various NAFDAC Registration Numbers (NRNs) “were found at the Europharm Laboratories site during investigation”
List among the drugs were Linocloxin (Ampicillin 125mg and Cloxacillin 125mg) powder for oral suspension 100ml NRN 04-4576 2, Linromycine (Erythromycin) powder for suspension 100ml NRN 04-4573, Linocillin (Ampicillin) powder for oral suspension 50ml NRN 04-4560, Linmoxyn (Amoxicillin 125mg) suspension 60ml NRN 04-4567, and Eurogyl (Metronidazole suspension) 50ml NRN 04-4568.
Also included were Naflin (Cough Expectorant) 100ml NRN 04-4558, Natacid (Magnesium Trisilicate suspension) 100ml NRN 04-5752, Navit-B Syrup (Vitamin B Complex) 100ml NRN 04-4572, Fountain B-12 (Blood Tonic) 100ml NRN 04-4569, Fountain B-12 (Blood Tonic) 200ml NRN 04-4569, and Vitamin-C Syrup 100ml NRN 04-5001.
NAFDAC said others were Eurogyl (Metronidazole) Tablet blister 10×10 tabs NRN 04-4563, Eurogyl (Metronidazole) x1000 tablets NRN 04-4563, Euramol (Paracetamol) x1000 tablets NRN 04-4564, Euramox (Mebendazole 100mg) tablets NRN 04-4566, Linotrim (Cotrimoxazole suspension) 50ml NRN 04-4574, and Linoquine (Chloroquine Phosphate syrup 80mg/5ml) 60ml NRN 04-4571.
“Distributors, retailers, healthcare professionals, and caregivers are hereby advised to exercise caution and vigilance throughout the supply chain to prevent the distribution, sale, and use of substandard products.
Source: Channels TV
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