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费森尤斯卡比（美国）

争议事件

以下收录公开来源中与该品牌相关的争议事件。列出一条并不表示过错已经证实。

返回词条共 2 条

  1. 2026

    费森尤斯卡比因玻璃颗粒召回Tyenne关节炎注射液批次

    宣布召回

    费森尤斯卡比因内部调查发现产品中存在玻璃颗粒，对Tyenne（托珠单抗-aazg）注射液400 mg/20 mL瓶的一个批次发起全国召回。公司警告玻璃颗粒可能导致局部刺激、静脉炎症、血管阻塞和凝血、肺栓塞、永久性器官损伤或死亡。该召回由FDA于8月11日公布，涉及批号16UI07（NDC 65219-594-20），于2026年3月3日至25日发货，有效期至2028年8月，已销往美国各地的批发商、分销商和客户。

    品牌回应

    • 召回 — Fresenius Kabi

      Fresenius Kabi, a pharmaceutical company based in Illinois, has initiated a nationwide recall of one lot of an arthritis injection medication due to the presence of glass particles.

    • 持续披露 — Fresenius Kabi

      According to the announcement, Fresenius Kabi is currently notifying customers and distributors through letters and is arranging for the recalled products to be returned.

    来源摘录

    • According to the announcement, Fresenius Kabi is currently notifying customers and distributors through letters and is arranging for the recalled products to be returned.
    • The recall applies to Tyenne (tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL) 20 mL vials, the company said in an announcement published by the Food and Drug Administration on Aug. 11.
    • Fresenius Kabi, a pharmaceutical company based in Illinois, has initiated a nationwide recall of one lot of an arthritis injection medication due to the presence of glass particles.
    来源

  2. 2020

    QuVa Pharma召回部分R.E.C.K.产品批次

    宣布召回

    QuVa Pharma宣布自愿召回所有使用Fresenius Kabi召回的酮咯酸制备的R.E.C.K. 50毫升产品批次。QuVa表示已联系受影响的医院药房客户，并要求隔离库存产品、申报未使用数量及退回成品销毁。报道指出，酮咯酸被召回是因为留样瓶中发现颗粒物。

    来源摘录

    • QuVa Pharma, Inc. confirms that is working with the U.S. Food and Drug Administration, and voluntarily recalling all lots of R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe that were prepared using sterile Ketorolac being recalled by Fresenius Kabi.
    • QuVa has reached out to all hospital pharmacy customers who purchased product from the lots affected and has asked them to: quarantine anything that is in stock to prevent use in direct patient care; complete a return response form to capture the amount of unused product; and return the finished goods to QuVa for destruction.
    • Fresenius Kabi recalled multiple lots of Ketorolac on April 20, 2020 due to the presence of particulate matter found in the reserve sample vials.
    来源