Human Medicines Recall Announcements in Saudi Arabia Between 2017 and 2022: An Analysis of Saudi Food and Drug Authority (SFDA) Reports

• Published in: Therapeutic innovation & regulatory science 2024-07, Vol.58 (4), p.689-695
• Main Authors: Almutairi, Malak, Algabbani, Aljoharah, Alasiri, Ajbaa, Alhomaidan, Ali, Alqahtani, Amani S.
• Format: Article
• Language: English
• Subjects: Contamination; Data analysis; Defective products; Defects; Drug Industry; Drug Recalls; Drug Safety and Pharmacovigilance; Drugs; Humans; Medical innovations; Medicine; Original Research; Pharmaceutical industry; Pharmaceuticals; Pharmacotherapy; Pharmacy; Product recalls; Product Recalls and Withdrawals; Retrospective Studies; Saudi Arabia; Specifications
• ISSN: 2168-4790; 2168-4804; 2168-4804
• DOI: 10.1007/s43441-024-00635-4

Purpose This study aims to explore the characteristics of drug recall announcements issued over six years by the SFDA in Saudi Arabia. Additionally, to examine the patterns of voluntary drug recall requests by pharmaceutical companies (both innovator and generic) in response to product defects. Methods A retrospective data analysis was conducted on drug recall announcements issued by the SFDA between 2017 and December 2022. The study included recalls of registered and unregistered drugs posted on the SFDA Drugs Circulars and Withdrawal webpage. Descriptive analysis was performed on relevant variables: recall year, therapeutic class, recall type, pharmaceutical company type, recall reasons and voluntary or involuntary product defect reports. Results During the study period, a total of 371 products were recalled, with the majority being involuntary recalls (82.4%). About two-thirds of the recalls (66.0%) were related to registered products. The most common reasons for recalls were non-compliance with the manufacturer's specifications (33.2%), 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 recalls of defective products. Innovator pharmaceutical companies requested 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. Significantly, more innovative pharmaceutical companies request voluntary recalls for product defects compared to generic pharmaceutical companies.