The Federal Service for Surveillance in Healthcare informs about the receipt of the information on the detection within the framework of inspections for federal state control (supervision) in the field of drug circulation FGBU “Information and Methodological Center for Expertise, Accounting and Analysis of the Circulation of Medical Products” of Roszdravnadzor (Khabarovsk branch) drug “Amiodarone, concentrate for the preparation of a solution for intravenous administration 50 mg/ml 3 ml, ampoules (5), blister packs (2), packs of cardboard” series 040319, 231119 produced by LLC “Ellara” (Russia), the quality of which does not meet the established requirements of regulatory documents for the following indicators: “Mechanical inclusions” (series 231119), “Related impurities” (series 040319);

Data source and details