In accordance with the results of the examination carried out in the Laboratory of expertise and quality control of medical and pharmaceutical products of Analytical Expertise Center of the Ministry of Health and on the basis of the application of the Administration of Regional Medical Divisions (TƏBİB) No. 18-1-89/2-132/2024, and with the “rule for recall of medicines” (hereinafter referred to as the rule), approved by Resolution of the Cabinet of Ministers of the Azerbaijan Republic dated November 27, 2019 No. 460, established:
As a result of laboratory studies conducted on samples of “Aminoselect 500 ml solution for injection” and “Aminoselect 250 ml solution for injection” belonging to the Italian manufacturer “Industria Farmasyutica Galenika Senese SR”, which were submitted to the Center from several city and district hospitals for the purpose of quality control, the samples of the tested liquids were the presence of dark-colored particles visible to the eye (according to the requirement of the normative document submitted by the manufacturer, there should not be mechanical mixtures or foreign substance particles inside the medicine intended for intravenous injection).
For this reason, the recall level of the specified medicines is assigned to 1 (Cases where the medicines poses and may pose a danger to human life and health), the recall level of the medicines is assigned to level “A” (to the end user).
Based on the above, guided by subclause 4.1.3 of the rules, a decision was made to recall a medicine owned by the Italian company “Industria Farmaceutica Galenica Senese SR”, called “Aminosel injection solution 500 ml”, series: 2300311; 2300312 and “solution for injection aminocel 250 ml”, series: 2301012, 2301013, 2300469, 2300470.
