This study aimed to assess the characteristics of Rwandan FDA recall products and determine the association between the classes of recall and recall characteristics. The study revealed that a large proportion of recalled products belonged to Class A of the WHO, and ACT classification and antibiotics constituted 28.3% of the recalled products. Class I recall accounted for 33.0% of all recalls; contamination emerged as a leading cause, accounting for 26.4% of recalled products. A significant association was found between the class of recall and many recall characteristics, including the year of recall, drug category, safety issues, reporter, and manufacturing countries.
Class A of the ATC classification represented a large proportion of recalled products, followed by class J and class C. In the ATC classification groups, the drugs are classified according to the organ or system on which their active substances act based on their chemical, therapeutic or pharmacological properties (12). Class A stands for Alimentary tract and metabolism, class C is for cardiovascular system and class J is for anti-infective for systemic use (12).
Antibiotics constituted 28.3% of the recalled products, and antiparasitic drugs represented 12.3%. Using defective or poor-quality antibiotics can lead to antibiotic misuse and overuse, which is a contributing factor to antimicrobial resistance (13–15). This is an alarming finding in a low-income country such as Rwanda, where antibiotic misuse is an issue and antibiotic resistance is emerging (14, 16–19). Furthermore, in addition to the measures that are in place to protect antibiotics, using defective or poor-quality antiparasitics would impede WHO control and response to eliminate soil-transmitted helminths (20); therefore, additional measures should be directed to protect antiparasitics, especially in countries where parasitic infestation, including malaria and helminthic infestation, is still high (21–23).
Disinfectants accounted for 11.3% of product recalls, a noteworthy proportion. This prominence is likely attributed to the temporal overlap of our study period with the era of COVID-19, during which the utilization of hand sanitizers and other disinfectants significantly increased in comparison to the periods preceding and following the pandemic. Nevertheless, despite the WHO declaration that COVID-19 no longer poses a Public Health Emergency of International Concern (PHEIC) (24), it remains imperative to sustain pharmacovigilance efforts concerning disinfectants. These substances serve various purposes, and substandard quality can potentially engender severe health consequences, particularly in the context of healthcare-associated or nosocomial infections and surgical site infections, in addition to harming the users (25, 26).
Contamination emerged as a leading cause of product recalls. Kelsey et al. also found that contamination was an important reason for product recalls in the USA (4). The prevalence of contamination as a leading cause emphasizes the critical importance of rigorous quality control protocols throughout the production and distribution chain.
Class I recall accounted for 33% of all recall, with 75.4% of the recalls involving antihypertensive drugs and 60% related to diagnostic agents being classified as Class I. Class I recalls are typically associated with products that pose a significant risk of adverse health consequences or even death (2). The prevalence of class I recalls among antihypertensive and diagnostic agents emphasizes the importance of rigorous quality control, monitoring, and postmarket surveillance among these categories of drugs.
The trends in recall incidences over time were notable, with 21.7% of drugs recalled in 2019 and 51.9% recalled in the subsequent year, 2020. This incidence declined to 17.9% in 2021 and further to 8.5% in 2022. Given that the Rwandan FDA was established in 2018, the relatively low incidence of drug recall in 2019 may suggest an early stage of vigilance within the regulatory framework. The significant increase that was observed in 2020 could be attributed to the heightened inspections in response to the changing circumstances of the COVID-19 pandemic coupled with the influx of COVID-19-related products into the market. The subsequent decline in drug recall in 2021 and 2022 may signify the stabilization of pharmaceutical product safety measures, improved quality control, adherence to safety regulations, and enhanced recall efficacy. However, further investigations are warranted to gain a deeper understanding of the factors behind these shifts.
Nongovernmental entities supplied the majority of the recalled products (63.2%), and governmental (affiliated with a public institution) entities supplied 13.2%. Nongovernmental suppliers accounted for 44.8% of Class II recalls, while governmental suppliers accounted for 92.9% of Class II recalls. This may call for a more thorough investigation of the procedures and quality control mechanisms used by both governmental and nongovernmental suppliers. Additionally, it raises questions about whether specific interventions or guidelines are required to enhance product quality and safety, particularly among governmental suppliers. This disparity may also reflect potential differences in oversight and regulation between these two supplier types.
India emerged as a predominant source of recalled products, accounting for 29.2% of the total recall, but many Indian products fell into Class II recalls (80.6%). This highlights the need for heightened vigilance in quality control within its pharmaceutical industry and underlines the importance of vigilance for products imported from India. This highlights the necessity of strengthening the regulatory system, primarily through the enhancement of inspections for good manufacturing practices, the improvement of registration procedures, and the enhancement of postmarketing surveillance for pharmaceutical products. To enhance pharmaceutical safety globally, collaborative efforts among countries, industry stakeholders, and regulatory bodies are important (27).
All recalled products from France were classified as class I recalls, and 100% of all spasmolytic drugs also fell into the class I recall category. This observation can be attributed to the noteworthy fact that multiple batches of Debridat, a spasmolytic medication, were subject to recalls due to contamination, and all these batches originated from France.
This study has limitations. First, as a descriptive cross-sectional study including secondary analysis of drug recall data, data completeness posed an issue. Second, this study could not identify the root causes of contamination, poor quality, and other safety issues that limit the ability to implement targeted implementation and preventive measures. Additionally, it is important to note that the study primarily focuses on Rwanda's pharmaceutical recall landscape, and as such, the results may not be generalizable. To address these limitations, future research could adopt a broader perspective, including comparisons with international recall practices, to offer valuable insights into global best practices and potential areas for improvement. Furthermore, exploring the influence of the regulatory framework on recall decisions and outcomes could provide a deeper understanding of the interplay between regulations, industry practices, and patient safety.
Based on the findings, it is recommended that the Rwandan FDA and other regulatory agencies collaborate closely with manufacturers, suppliers, and healthcare providers to implement proactive measures. Strengthening the regulatory system is key to reducing the frequency and impact of recalls, especially since many recalled products are vital drugs with significant implications for their use and public health policies.