Risk of Unexpected Adverse Effects and Voluntary Recalls of Pharmaceuticals
First written in FY2016. 21 of 24 entries say "Restated". Latest entry: FY2024.
The whole theme swung hardest in 2026: 6 of 20 companies on the "Worse" side.
36 other companies' latest entry also says "Restated".
- FY2024RestatedAnnual report
「Unexpected adverse reactions may be identified after a drug is launched. Because we primarily handle essential medicines such as artificial-kidney dialysis solutions and infusion products, the likelihood of these risks materializing is considered relatively low. However, as long as we sell pharmaceutical products, these risks may materialize.」
While adding the assessment that the likelihood of risks materializing is relatively low because the business is centered on essential medicines, it maintains the risks of recalls and other consequences resulting from adverse reactions or safety problems. - FY2024-Q3RestatedAnnual report
「During the first three quarters of the current fiscal year, there were no new occurrences of the major risks that management recognises could materially affect the filing company's financial position, operating results or cash flows among the matters relating to business conditions, financial conditions and other matters described in the quarterly report, and no material changes to the "Business and Other Risks" described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes to the key risks, including adverse reactions and voluntary product recalls. - FY2024-Q1RestatedAnnual report
「There were no new major risks during the three months ended 30 June, and no material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes to the key risks, including adverse reactions and voluntary product recalls. - FY2023-Q3RestatedAnnual report
「During the first three quarters of the current fiscal year, there were no new occurrences of the major risks that management recognises could materially affect the filing company's financial position, operating results or cash flows among the matters relating to business conditions, financial conditions and other matters described in the quarterly report, and no material changes to the "Business and Other Risks" described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes to the key risks, including adverse reactions and voluntary product recalls. - FY2022SoftenedAnnual report
「Because we primarily handle essential medicines such as artificial-kidney dialysis solutions and infusion products, the likelihood of these risks materializing is considered relatively low. However, as long as we sell pharmaceutical products, these risks may materialize. We carry insurance covering liabilities such as product liability, but there is no guarantee that insurance proceeds will be paid in every case involving a serious adverse reaction or other safety problem with a product. Product recalls or discontinuation of sales could result in lower revenue, recall-related costs and significant damage to our brand image.」
While adding the assessment that the likelihood of risks materializing is relatively low because the business is centered on essential medicines, it continues to describe the possibility of recalls, discontinuation of sales, related costs and brand damage resulting from adverse reactions or safety problems. - FY2021Details of safety risks and insurance coverageAnnual report
「We carry insurance covering liabilities such as product liability. However, there is no guarantee that insurance proceeds will be paid in every case involving a serious adverse reaction or other safety problem with a product. Product recalls or discontinuation of sales could result in lower revenue, recall-related costs and significant damage to our brand image.」
It provides details of adverse-reaction and safety risks, noting the insurance coverage while specifying that payment of insurance proceeds is not guaranteed in all cases and that lower revenue, recall-related costs and brand damage may result. - FY2021-Q3RestatedAnnual report
「During the first three quarters of the current fiscal year, there were no new occurrences of the major risks that management recognises could materially affect the filing company's financial position, operating results or cash flows among the matters relating to business conditions, financial conditions and other matters described in the quarterly report, and no material changes to the "Business and Other Risks" described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes to the key risks, including adverse reactions, voluntary product recalls and discontinuation of sales. - FY2021-Q2RestatedAnnual report
「During the cumulative second quarter under review, there were no new major risks that management recognizes could have a material impact on the financial condition, operating results or cash flows of the filing company, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes to the key risks, including adverse reactions, voluntary product recalls and discontinuation of sales. - FY2021-Q1RestatedAnnual report
「There were no new major risks during the three months ended 30 June, and no material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes to the key risks, including adverse reactions, voluntary product recalls and discontinuation of sales. - FY2020-Q3RestatedAnnual report
「During the cumulative third quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes to business and other risks, including adverse reactions, voluntary product recalls and discontinuation of sales. - FY2020-Q2RestatedAnnual report
「During the cumulative second quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes to business and other risks, including adverse reactions, voluntary product recalls and discontinuation of sales. - FY2020-Q1RestatedAnnual report
「During the cumulative first quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes to business and other risks, including adverse reactions, voluntary product recalls and discontinuation of sales. - FY2019RestatedAnnual report
「Unexpected adverse reactions may be identified after a drug is launched. If a new adverse reaction is identified, business results may be affected by a voluntary product recall, discontinuation of sales or other actions.」
It continues to describe the possibility that adverse reactions identified after launch could lead to voluntary product recalls or discontinuation of sales. - FY2019-Q3RestatedAnnual report
「During the cumulative third quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes to business and other risks, including adverse reactions, voluntary product recalls and discontinuation of sales. - FY2019-Q2RestatedAnnual report
「During the cumulative second quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes to business and other risks, including adverse reactions, voluntary product recalls and discontinuation of sales. - FY2019-Q1RestatedAnnual report
「During the cumulative first quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes to business and other risks, including adverse reactions, voluntary product recalls and discontinuation of sales. - FY2018RestatedAnnual report
「Unexpected adverse reactions may be identified after a drug is launched. If a new adverse reaction is identified, business results may be affected by a voluntary product recall, discontinuation of sales or other actions.」
It continues to describe the possibility that adverse reactions identified after launch could lead to voluntary product recalls or discontinuation of sales. - FY2018-Q3RestatedAnnual report
「During the cumulative third quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes to business and other risks, including adverse reactions, voluntary product recalls and discontinuation of sales. - FY2018-Q1RestatedAnnual report
「During the cumulative first quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes to business and other risks, including adverse reactions, voluntary product recalls and discontinuation of sales. - FY2017RestatedAnnual report
「Unexpected adverse reactions may be identified after a drug is launched. If a new adverse reaction is identified, business results may be affected by a voluntary product recall, discontinuation of sales or other actions.」
It continues to describe the possibility that adverse reactions identified after launch could lead to voluntary product recalls or discontinuation of sales. - FY2017-Q3RestatedAnnual report
「During the cumulative third quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes to the risks of unexpected adverse drug reactions and voluntary product recalls. - FY2017-Q2RestatedAnnual report
「During the cumulative second quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes to the risks of unexpected adverse drug reactions and voluntary product recalls. - FY2017-Q1RestatedAnnual report
「During the cumulative first quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」
It states that there have been no material changes to the risks described in the previous fiscal year. - FY2016First statedAnnual report
「Unexpected adverse reactions may be identified after a drug is launched. If a new adverse reaction is identified, business results may be affected by a voluntary product recall, discontinuation of sales or other actions.」
It indicates that the identification of adverse reactions after launch could lead to voluntary product recalls, discontinuation of sales and an impact on business results.