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3类药品召回:Aspire Pharma Limited,托吡卡胺1%滴眼液,单剂量容器溶液 20 x 0.5ml,EL(26)A/47

UK MHRA · 2026-11-05 11:00

正文 · 中文译文

3类药品召回:Aspire Pharma Limited,托吡卡胺1%滴眼液,单剂量容器溶液 20 x 0.5ml,EL(26)A/47 Aspire Pharma Ltd正在召回托吡卡胺1%滴眼液(单剂量容器溶液,0.5ml x 20)的特定批次,原因是这些批次被标注了错误的有效期。这些批次的正确有效期应为31/10/2026。 来自: 药品和健康产品管理局 发布日期: 2026年11月5日 信息类型: 药品召回/通知 医学专业: 配药全科诊所和药房 签发日期: 2026年11月5日 目录 DMRC参考编号 上市许可持有人 药品详情 托吡卡胺1%滴眼液,单剂量容器溶液 20 x 0.5ml 受影响批号 背景 致医疗专业人员的建议 致患者的建议 附加信息 下载文件 DMRC参考编号 DMRC-41341621 上市许可持有人 Aspire Pharma Ltd 药品详情 托吡卡胺1%滴眼液,单剂量容器溶液 20 x 0.5ml PL:35533/0198 活性成分:托吡卡胺 SNOMED代码:45542111000001107 GTIN:5060209733661 受影响批号 批号 有效期 包装规格 首次分销 E941A 30/04/2027* 20 29/10/2025 E941B 30/04/2027* 20 04/02/2026 E941C 30/04/2027* 20 20/02/2026 *包装上印有错误的有效期 背景 Aspire Pharma Ltd 正在召回上述特定批次的托吡卡胺 1% 滴眼液,单剂量容器装溶液 0.5ml x 20,原因是这些批次标示的有效期不正确。这些批次的正确有效期应为 31/10/2026。 医护人员建议: 立即停止供应上述批次。将所有剩余库存隔离,并使用供应商批准的流程退回供应商。 患者建议: 患者无需采取进一步措施。本次召回是在药房和批发商层面作为预防措施进行的。 持有这些批次的患者应继续使用滴眼液,并联系其处方医生以获得替代处方。迄今为止,尚未收到因该缺陷导致的不良事件报告。 出现不良反应或对药物有任何疑问的患者应就医。任何疑似不良反应也应通过 MHRA 黄卡计划报告。 附加信息: 如需所有医疗信息咨询和该产品信息,请发送电子邮件至 medinfo@aspirepharma.com,或致电 01730 231148。 如需库存控制咨询,请发送电子邮件至 customerservices@aspirepharma.com,或致电 01730 231148。 本药品召回通知的接收者应通过本通知副本将此告知相关联系人。请 NHS 区域团队将此转发给社区药剂师和配药全科医生以供参考。 此致敬礼 缺陷药品报告中心 南柱廊10号 金丝雀码头 伦敦 E14 4PU 电话 +44 (0)20 3080 6574 DMRC@mhra.gov.uk 下载文件 3类药品召回:Aspire Pharma Limited,托吡卡胺1%滴眼液,单剂量容器装溶液 20 x 0.5ml,EL(26)A/47 目录 探索该主题 警报与召回

正文 · 英文原文

Class 3 Medicines Recall: Aspire Pharma Limited, Tropicamide 1% Eye Drops, solution in single dose containers 20 x 0.5ml , EL(26)A/47 Aspire Pharma Ltd is recalling specific batches of Tropicamide 1% Eye Drops, solution in single dose containers 0.5ml x 20, due to them being labelled with the incorrect expiry date. The correct expiry date for these batches should be 31/10/2026. From: Medicines and Healthcare products Regulatory Agency Published: 5 November 2026 Message type: Medicines recall/notification Medical specialty: Dispensing GP practices and Pharmacy Issued: 5 November 2026 Contents DMRC reference number Marketing Authorisation Holder Medicine Details Tropicamide 1% Eye Drops, solution in single dose containers 20 x 0.5ml Affected Lot Batch Numbers Background Advice for Healthcare Professionals Advice for Patients Additional information Download document DMRC reference number DMRC-41341621 Marketing Authorisation Holder Aspire Pharma Ltd Medicine Details Tropicamide 1% Eye Drops, solution in single dose containers 20 x 0.5ml PL: 35533/0198 Active ingredient: tropicamide SNOMED code: 45542111000001107 GTIN: 5060209733661 Affected Lot Batch Numbers Batch No. Expiry Date Pack Size First Distributed E941A 30/04/2027* 20 29/10/2025 E941B 30/04/2027* 20 04/02/2026 E941C 30/04/2027* 20 20/02/2026 *Incorrect expiry date printed on packs Background Aspire Pharma Ltd is recalling the above specific batches of Tropicamide 1% Eye Drops, solution in single dose containers 0.5ml x 20, due to them being labelled with the incorrect expiry date. The correct expiry date for these batches should be 31/10/2026. Advice for Healthcare Professionals: Stop supplying the above batches immediately. Quarantine all remaining stock of these batches and return it to your supplier using your supplier’s approved process. Advice for Patients: No further action is required by patients. This recall is being undertaken as a precautionary measure at the Pharmacy and Wholesaler level. Patients in possession of these batches should continue to use the eye drops and contact their prescriber to obtain a replacement prescription. No reports of adverse incidents due to this defect have been received to date. Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme. Additional information: For all medical information enquiries and information on this product, please email medinfo@aspirepharma.com, or telephone 01730 231148. For stock control enquiries please email customerservices@aspirepharma.com, or telephone 01730 231148. Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information. Yours faithfully Defective Medicines Report Centre 10 South Colonnade Canary Wharf London E14 4PU Telephone +44 (0)20 3080 6574 DMRC@mhra.gov.uk Download document Class 3 Medicines Recall: Aspire Pharma Limited, Tropicamide 1% Eye Drops, solution in single dose containers 20 x 0.5ml , EL(26)A/47 Contents Explore the topic Alerts and recalls

English
Class 3 Medicines Recall: Aspire Pharma Limited, Tropicamide 1% Eye Drops, solution in single dose containers 20 x 0.5ml , EL(26)A/47
内容仅供参考,不构成诊疗建议,不能替代执业医师的诊断。

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