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

Overview

A retrospective analysis of drug recall reports issued by the Turkish Medicines and Medical Devices Agency (TITCK) between 2018 and 2024. The study examined 133 distinct pharmaceutical brands from 67 companies, identifying patterns in recall frequency, reasons, and regulatory classification levels across the seven-year period.

Methods and approach

Systematic retrospective analysis of drug recall reports published on the TITCK website from 2018 through 2024. Data regarding recalled drugs were extracted, catalogued, and analysed by temporal distribution (year), number of affected brands and manufacturers, reasons for recall, and regulatory recall classification level. No additional methodological specifications regarding data extraction protocols, validation procedures, or analytical statistical techniques were provided.

Key Findings

TITCK issued recall reports affecting 133 pharmaceutical brands distributed across 67 companies. Fourteen distinct reasons were identified as drivers of drug recalls. Primary reasons included contamination, particulate matter, foreign bodies, sterility deficiencies, warnings from the European Medicines Agency or Food and Drug Administration, packaging incompatibility, safety concerns, recommendations from TITCK Scientific Committees, and voluntary manufacturer-initiated recalls. Recalls were predominantly classified at 1st Class A (110 recalls) and 1st Class B (56 recalls) severity levels. Peak recall activity occurred in 2021, with 44 drugs from 30 companies subject to recall. Analysis indicated that recurrent recalls affected the same pharmaceutical companies, frequently associated with identical underlying causes.

Implications

The concentration of recalls among specific pharmaceutical manufacturers, particularly for consistent reasons, suggests systematic deficiencies in quality assurance or production processes at affected facilities. Implementation of targeted corrective action programs addressing identified recall causes could reduce frequency and severity of future regulatory actions. The prevalence of contamination, sterility, and particulate-related recalls indicates potential gaps in manufacturing controls and environmental monitoring protocols.

Scope and limitations

This summary is based on the study abstract and available metadata. It does not include a full analysis of the complete paper, supplementary materials, or underlying datasets unless explicitly stated. Findings should be interpreted in the context of the original publication.