Please be cautious and avoid using the specified series of medicine: Regulatory Authority

The Health and Labor Inspection Body of Armenia has issued a statement which notes: "Based on the decision No. 164-N of the Government of Armenia dated February 28, 2019, which establishes the procedure for notifying about drugs that are unregistered or do not meet quality requirements or are expired or have had their registration revoked or suspended, or have been imported in violation of the legislation of the Republic of Armenia, as well as counterfeit drugs, drug substances, herbal raw materials, and the recall procedure, and in accordance with Article 23, Part 2 of the Law on Medicines of the Republic of Armenia, as well as the expert conclusion received from the ‘Academic E. Gabrielian Center for Expertise of Drugs and Medical Technologies’ LLC dated May 8, 2023, No. 01/1449-23, it has been reported that during the use of the medicine with the series number 22.299.04A, ‘Sodium Chloride 0.9% (9mg/ml) injection solution, 500 ml plastic packaging’, symptoms typical of pyrogenic reactions were recorded.

According to the expert conclusion, there is a suspicion of contamination (first and (or) second class) for the sterile medicine intended for injection. The manufacturer of the medicines, ‘PHARMATEC’ LLC, has been issued an order to temporarily suspend the circulation of the specified series of the medicine.

Dear citizens, please be careful and avoid using this series of medicine until the results of the additional examinations are concluded."