Content analysis of drug recall announcements in Saudi Arabia: Between 2016 and 2022

Abstract

Abstract Purpose This study aims to analyze drug recall reports issued by the Saudi Food and Drug Authority (SFDA) in Saudi Arabia over seven years and describe the practice of pharmaceutical companies regarding voluntary drug recalls. Methods A retrospective data analysis was conducted on drug recall announcements issued by the SFDA between July 2016 and December 2022. The study included registered and unregistered drug recalls posted on the SFDA Drugs Circulars and Withdrawal webpage. Descriptive analysis was performed on variables such as recall year, report language, number of report items, depth of recall, product name, therapeutic class, product registration status, recall type, pharmaceutical company type, recall reasons, and voluntary or involuntary product defect reports. Results During the study period, a total of 375 products were recalled, with the majority being involuntary recalls (82.7%). Over two-thirds of the recalls (66.4%) were related to registered products. The most common reasons for recalls were non-compliance with manufacturer's specifications (33.3%), contamination (23.7%), and violations (20.5%). A total of 109 pharmaceutical companies were associated with the recalled products, with (85.3%) being generic pharmaceutical companies. The majority of innovator pharmaceutical companies (68.8%) requested voluntary drug recall of defective products. Innovator pharmaceutical companies tended to request voluntary recalls more often than generic pharmaceutical companies. Conclusion The study findings highlight the most frequent causes of drug recalls and the patterns of voluntary recall requests by pharmaceutical companies. Non-compliance with manufacturer's specifications was the most common reason for recalls. Innovator pharmaceutical companies were more likely to request voluntary recalls for product defects compared to generic pharmaceutical companies.