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Journals / Balıkesir Sağlık Bilimleri Dergisi / 2026 / Volume: 15 Issue: 1

Analysis of Turkish Medicines and Medical Devices Agency Drug Recall Reports Between 2018-2024

Türkiye İlaç ve Tıbbi Cihaz Kurumu'nun 2018-2024 Yılları Arasındaki İlaç Geri Çağırma Raporlarının Analizi

Tolgay Ercan(SİVAS CUMHURİYET ÜNİVERSİTESİ, YILDIZELİ MESLEK YÜKSEKOKULU, TIBBİ HİZMETLER VE TEKNİKLER BÖLÜMÜ)0000-0002-6893-4358
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Publication Date
2026-02-28
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AI Summary & Key Takeaways

AI Insight
⚡ TL;DR(Too Long; Didn't Read)

The voluntary recall requests of licensed companies could be seen as an effort by companies to produce quality drugs.

📌 3 Key Takeaways

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Objective & Hypothesis:Objective: The reasons and characteristics of drug recalls by TITCK between 2018-2024 were analysed.
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Key Findings & Data:Materials and Methods: A retrospective analysis of drug recalls between 2018-2024 was conducted on the TITCK website.
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Conclusion & Impact:The voluntary recall requests of licensed companies could be seen as an effort by companies to produce quality drugs.
🔬Design:Research Article
📍Scope:2018-2024 Verileri
⚙️Variables:Drug Recalls · Drug Safety · Recall Information

Abstract

Objective: The reasons and characteristics of drug recalls by TITCK between 2018-2024 were analysed. Materials and Methods: A retrospective analysis of drug recalls between 2018-2024 was conducted on the TITCK website. Data on drug recalls were investigated and systematically listed. Data were analysed by year for the number of drugs and the level of drug recall. Result: Between 2018-2024, TITCK issued drug recall reports for 133 different brands belonging to 67 pharmaceutical companies. It is seen that 14 reasons are effective in the recall of drugs. Contamination, particles, foreign bodies, sterility, European Medicines Agency (EMA), Food and Drug Administration (FDA) warnings, packaging incompatibility, safety problems, TITCK Scientific Committees or the voluntary recall request of the licensed company are among the most notable drug recall reasons. The highest numbers of recalls were observed in 1st Class A level (110 recalls) and 1st Class B level (56 recalls). The most recalls were made in 2021 with 30 companies and 44 drugs. Conclusion: It is seen that the same pharmaceutical companies are experiencing drug recalls, especially for the same reason. If pharmaceutical companies focus on the reasons for the recall, the number of recalls may decrease. Regular preparation of drug recall reports by TITCK Scientific Committees could minimize possible safety-related errors. The voluntary recall requests of licensed companies could be seen as an effort by companies to produce quality drugs.

Özet

Amaç: TİTCK tarafından 2018-2024 yılları ilaç geri çekmelerinin nedenleri ve özellikleri analiz edilmiştir. Gereç ve Yöntem: TİTCK internet sitesinde 2018-2024 yılları geri çekilen ilaçların retrospektif analizi yapılmıştır. İlaç geri çekmelerine ait veriler araştırılmış ve sistematik olarak sıralanmıştır. Veriler ilaç sayısı, ilacın geri çekilme seviyesi yıllara göre analiz edilmiştir. Bulgular: 2018-2024 yılları arasında TİTCK 67 ilaç firmasına ait 133 farklı markada ilaç geri çekme raporu düzenlenmiştir. Geri çekilen ilaçlarda 14 nedenin etkili olduğu görülmektedir. Etkenler arasında kontaminasyon, partikül, yabancı cisim, sterilite, European Medicines Agency (EMA), Food and Drug Administration (FDA) uyarıları, ambalaj uyumsuzluğu, güvenlik sorunları, TİTCK Bilimsel Kurulları ya da ruhsat sahibi firmanın gönüllü geri çekme talebi en dikkat çeken ilaç geri çekme nedenleri arasındadır. En fazla geri çekmenin 1. Sınıf A seviyesinde (110) ve 1. Sınıf B seviyesinde (56) olduğu görülmektedir. En fazla 2021 yılında 30 firma ve 44 ilaç ile geri çekme olmuştur. Sonuç: Özellikle aynı sebepten dolayı aynı ilaç firmalarının ilaç geri çekme yaşadıkları görülmektedir. İlaç firmaları geri çekme nedenlerine odaklanırsa geri çağırma sayısında azalma yaşanabilir. TİTCK Bilimsel kurullarının ilaç geri çekme raporlarının düzenli olarak yapılması güvenlikle ilgili oluşabilecek hataları minimum düzeye düşürebilir. Ruhsat sahibi firmaların gönüllü geri çekme taleplerinin olması firmaların kaliteli ilaç üretme çabası olarak görülebilir.

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Cite This Article

Ercan, T. (2026). Analysis of Turkish Medicines and Medical Devices Agency Drug Recall Reports Between 2018-2024. Balıkesir Sağlık Bilimleri Dergisi, Volume: 15 Issue: 1. https://doi.org/10.53424/balikesirsbd.1712550

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