The National Agency for Food and Drugs Administration and Control (NAFDAC) is informing the healthcare providers and the general public of the nationwide mop up of all products produced and distributed by EUROPHARM LABORATORIES.
NAFDAC commenced this 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 authorization (MA).
During the investigation, several products were discovered at the facility, many of which were being produced or distributed in violation of NAFDAC regulations. As part of the investigation, laboratory analysis was conducted on some of products which further confirmed significant quality failures, raising serious public health concerns.
Result of 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% and 18.4% (far below acceptable limits).
- Linmoxyn (Amoxicillin 500mg capsules) also failed, with API content of only 48.3%, confirming it to be grossly substandard.
Risk Statement
The risk of low Active Pharmaceutical Ingredient (API) in medicines includes treatment failure, antimicrobial resistance, and potential safety concerns to consumers.
Product details
The following products bearing various NAFDAC Registration Numbers (NRNs)—were found at the Europharm Laboratories site during investigation:
Name & Address of Manufacturer: Europharm Laboratories, Eurolink Nigeria Limited, Plot Pl., 7354, Anglo Jos, New Ind. Area, Zarmaganda, Jos, Nigeria
S/N | Product Name | NRN |
1 | Linocloxin (Ampicillin 125mg & Cloxacillin 125mg) powder for oral suspension 100ml | NRN 04-4576 |
2 | Linromycine (Erythromycin) powder for suspension 100ml | NRN 04-4573 |
3 | Linocillin (Ampicillin) powder for oral suspension 50ml | NRN 04-4560 |
4 | Linmoxyn (Amoxicillin 125mg) suspension 60ml | NRN 04-4567 |
5 | Eurogyl (Metronidazole suspension) 50ml | NRN 04-4568 |
6 | Naflin (Cough Expectorant) 100ml | NRN 04-4558 |
7 | Natacid (Magnesium Trisilicate suspension) 100ml | NRN 04-5752 |
8 | Navit-B Syrup (Vitamin B Complex) 100ml | NRN 04-4572 |
9 | Fountain B-12 (Blood Tonic) 100ml | NRN 04-4569 |
10 | Fountain B-12 (Blood Tonic) 200ml | NRN 04-4569 |
11 | Vitamin-C Syrup 100ml | NRN 04-5001 |
12 | Eurogyl (Metronidazole) Tablet blister 10×10 tabs | NRN 04-4563 |
13 | Eurogyl (Metronidazole) x1000 tablets | NRN 04-4563 |
14 | Euramol (Paracetamol) x1000 tablets | NRN 04-4564 |
15 | Euramox (Mebendazole 100mg) tablets | NRN 04-4566 |
16 | Linotrim (Cotrimoxazole suspension) 50ml | NRN 04-4574 |
17 | Linoquine (Chloroquine Phosphate syrup 80mg/5ml) 60ml | NRN 04-4571 |
All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the substandard products within the zones and states.
Distributors, retailers, healthcare professionals and caregivers are hereby advised to exercise caution and vigilance within the supply chain to avoid the distribution, sale and use of the substandard products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Healthcare professionals and consumers are advised to report any suspicion of sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
NAFDAC………. Customer-focused, Agency-minded!!!
