Circulation of Sodium Chloride Series 23.088.01B Halted

The circulation of the medicinal product "Sodium Chloride 0.9% (9 mg/ml) infusion solution, 200 ml plastic containers" of series 23.088.01B has been temporarily suspended, as well as the product "Sodium Chloride 0.9% (9 mg/ml) infusion solution, 500 ml plastic containers" of series 23.156.03A. This was announced by the Health and Labor Inspection Body of Armenia.

The decision was based on a letter received on July 6, 2023, from the Expert Center for Pharmaceuticals and Medical Technologies named after Academician E. Gabrielyan under the Ministry of Health of Armenia, referenced 01/2164-23 dated July 4, 2023, along with the accompanying expert conclusion.

According to the conclusion, during the application of the products, symptoms characteristic of pyrogenic reactions were recorded, and there is a suspicion of defects subject to recall (first and/or second class).