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 violate safety laws. Action can be initiated by the manufacturing company
or by the order of a regulatory body. This study aimed to assess the characteristics of Rwanda 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 Rwanda FDA in the section assigned to “Safety alerts”. The search included data
reported between February 2019 and February 2023 covering four years. 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. Categorical
variables were described in terms of counts and relative frequencies. Bivariate analyses used Pearson’s chi-square test
to illustrate the associations between categorical independent variables and recall classes.
Results The study revealed that a large proportion (33.0%) of the recalled products belonged to Class I. Antibiotics
constituted 35.8% of the recalled products, with contamination emerging as a leading cause and responsible
for 26.4% of the 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%). An association was found between the class
of recall and several recall characteristics, including the year of recall, drug category, safety issues, reporter, and manufacturing
country.
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 provide evidence-based strategies
to enhance drug quality, safety, efficacy, regulatory compliance, and patient welfare.
Keywords Drug recall, Rwanda FDA, Quality issues, Class of recall