Suspension Of Farma Mediterrania Manufacturing Company

NAFDAC 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 pharmacovigilance@nafdac.gov.ng

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