A four-year assessment of the characteristics of Rwandan FDA drug recalls

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Abstract Background A drug recall is an act of removing products from the market and/or returning them to the manufacturer for disposal or correction when they violated safety law. The action can be initiated by the manufacturing company or by the order of a regulatory body. This study aims to assess the characteristics of Rwandan FDA drug recall and determine the association between classes of recall and recall characteristics. Methodology This was a retrospective descriptive cross-sectional study. Data about recalled drugs were collected from the official website of the Rwandan FDA in the section assigned to “Safety alerts”. The search included the data reported between February 2019 and February 2023 covering a four-year period. Data cleaning was conducted in Microsoft Excel to address missing data and inconsistencies, followed by importation into STATA/SE software version 17.0 for further cleaning and subsequent analysis. Descriptive statistics were computed for independent variables, and categorical variables were described in terms of counts and relative frequencies. Bivariate analyses used Pearson’s chi-square test to illustrate associations between categorical independent variables and the classes of recalls. A p value of < 0.05 was considered statistically significant. Results The study revealed that a large proportion of recalled products belonged to Class I of the WHO’s ACT classification, with antibiotics constituting 28.3% of the recalled products. Class I recalls accounted for 33.0% of all recalls, with contamination emerging as a leading cause, responsible for 26.4% of the recalled products and 89.3% of class I recalls. India was the leading manufacturing country for the recalled products (29.2%), followed by France (17.9%), China (17.0%), Kenya (13.2%), and Russia (6.6%). The study also found a significant association between the class of recall and several recall characteristics, including the year of recall, drug category, safety issues, reporter, and manufacturing countries. Conclusion This study provides a comprehensive overview of the characteristics of drug recalls in Rwanda. The insights gained contribute to a nuanced understanding of recall dynamics and pave the way for evidence-based strategies to enhance drug quality, safety, efficacy, regulatory compliance and patient welfare.

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