The General Directorate of Public Health of the Ministry of Health reported that no undesirable effects that would require the recall of tetanus diphtheria vaccines belonging to a company were made, and that the series was withdrawn due to the commission decision due to some processes that were found to be deficient during the last inspection.
In the statement made by the General Directorate of Public Health, it was stated that each vaccine offered for use was re-analyzed at the Turkish Medicines and Medical Devices Agency (TİTCK) National Reference Laboratories, and after being sure of its effectiveness and safety, it was followed up with the Vaccine Tracking System until it was administered to the people.
It was stated that the product named “Tetadif 0.5 ml IM Injectable Suspension”, the withdrawal process of which was initiated by TITCK, is the first vaccine to be produced in Turkey from the first stage by providing adult tetanus diphtheria vaccine and technology transfer support.
In the statement, which stated that every process of production is followed regularly by TITCK, the following was noted:
“There was no undesirable effect notification that would require the recall of the vaccine in question, but due to some processes that were found to be deficient during the last inspection, the batch was withdrawn according to the decision of the commission. Newly produced vaccines are monitored under special conditions and their shelf life is gradually extended up to 3 years. The shelf life of the vaccine in question is also such a change. At the end of the process, it was extended from 2 years to 3 years. This is not the process of extending the expiration date of the vaccine in question. We have a sufficient stock of vaccines, which have been checked and are suitable for use. There is no problem in this respect.” (AA)