Status of Drug Recalls

Abstract

There are few reports summarizing the status of drug recalls. Therefore, we analyzed the voluntary product recall information published by Pharmaceuticals and Medical Devices Agency (PMDA) during the 3 years from April 1, 2017 to March 31, 2020. The number of voluntary recalls by year was 129 in fiscal year (FY) 2017, 150 in FY2018, and 156 in FY2019, for a total of 435 cases, and the total number of products collected was 701. Most of the original and generic products were voluntarily collected in class Ⅱ, and in 2019, serious class Ⅰ recalls increased due to the presence of the carcinogen N-nitrosodimethylamine in ranitidine preparations. The dosage form with the largest number of voluntary recalls was injection, followed by tablets. The reasons for recall were as follows: foreign substances in 44 items, 129 items that did not conform to the specifications, 177 items that deviated the marketing approval, 79 items that were recalled based on blood donation information, 68 items that were mislabeled, 34 items that were defective in containers, 7 items that were voluntarily recalled because of marketing approval deviation or misspecification, and 163 items for other reasons. There was correlation between the number of products handled and the number of voluntary recalls for manufacturers that mainly handle generic drug.