Survey of Drug Recalls―Issues for Improving the Reliability of Generic Drugs―

Abstract

In recent years, recalls of generic drugs which might affect the reliability in terms of health and supply have been reported. The objective of this study was to clarify the current status of drug recalls by investigating the number of drug recalls over time, and to examine issues for improving the reliability of generic drugs and promoting their use. The study covered prescription drugs recalled in the fiscal years of 2018-2022 (until September 2022). Recall information was categorized by drug class, drug type, dosage forms, therapeutic categories, reasons for recall, and the manufacturer/distributor, and analyzed by fiscal year. In 2018-2021, the total number of recalls increased each year (111 recalls in 2018, 141 in 2019, 271 in 2020 and 507 in 2021). There were 64 recalls in the first half of 2022. The percentage of recalls of generic drugs increased from 30.6%, 41.1%, 74.2%, to 91.1%. As the reasons of generic drug recalls, deviations from the approved specifications in stability monitoring, deviation from the approval document increased. There were also reasons that occurred only with generic drugs. In order to reduce the numbers of recalls and reestablish the reliability of generic drugs, there is a need to reestablish a quality control system and re-educate legal compliance on the generic drug industry.