Wednesday, 25 May 2016 10:58

Suspension Of Farma Mediterrania Manufacturing Company

The agency has recently been notified on the suspension of Farma Mediterrania, a drug manufacturing company based in Barcelona, Spain by European Medicine Agency Regulators. The FDA queries the quality assurance system of the company and finds the equipment and procedure used in their manufacturing stream as nonqualified.

The FDA also recalled all the pharmaceuticals produced by the company enlisted below:

Drug Specifications

S/N Active Ingredient Pharmaceutical Form Strength Presentation Classification
1 Alprostadi Solution for Injection 20µg/ml, 500µg/ml Liquid ampoules Prescription
2 Azithromycin Powder for Injection 500mg Lyophilised vials Prescription
3 Clarithromycin Powder for Injection 500mg Lyophilised vials Prescription
4 Colistimethate Powder for Injection 1 & 2mg/2ml Lyophilised vials Prescription
5 Dobutamine Solution for Injection 250mg/20ml Liquid 20ml ampoules Prescription
6 Esomeprazole Powder for Injection 40mg Lyophilised vials Prescription
7 Flumazenile Solution for Injection 0.1mg/ml 5 & 10ml Liquid Ampoules Prescription
8 Hydrocortisone Powder for Injection 100mg/ml, 500mg/5ml Lyophilised vials Prescription
9 Noradrenaline bitartrate Solution for Injection 1mg/ml 4, 5 & 10ml Liquid ampoules Prescription
10 Noradrenaline bitartrate Solution for Injection 2mg/ml 2, 4 & 20ml Liquid ampoules Prescription
11 Omeprazole Powder for Injection 40mg Lyophilised vials Prescription
12 Ondansetron Solution for Injection 2mg/ml 2 & 4ml Ampoules Prescription
13 Pantoprazole Powder for Injection 40mg Lyophilised vials Prescription
14 Phenytoin Solution for Injection 250mg/5ml Ampoules & Vials Prescription
15 Rivastigmine Oral solution 2mg/ml   Prescription
16 Ropivacaine Solution for Injection 20, 75 & 100mg Ampoules & bags Prescription
17 Teicoplanine Powder for Injection 200, 400mg Lyophilised vials Prescription
18 Vancomycin Powder for Injection 500mg, 1g Lyophilised vials Prescription
19 Vecuronium bromide Powder for Injection 10mg/3ml Lyophilised vials Prescription
20 Valproic acid Powder for Injection 400mg/4ml Lyophilised vials Prescription
21 Zolendronic Solution for Injection 4mg/5ml Liquid vials Prescription

Healthcare providers and consumers should report adverse events to NAFDAC PRASCOR (20543 – Toll free from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

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Read 9892 times Last modified on Wednesday, 25 May 2016 11:24



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