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辉瑞公司Hospira召回部分盐酸注射液Carpuject单位

Pfizer's Hospira Recalls Select Hydrochloride Injection Carpuject Units

RTTNews 2024-05-23 17:49 翻译由动脉网AI生成,点击反馈

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Hospira, Inc., affiliated to dug major Pfizer Inc., is recalling select lots of Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection Carpuject Units, according to the U.S. Food and Drug Administration.The recall was initiated due to the potential for incomplete crimp seals.

据美国食品和药物管理局(FDA)称,隶属于达格梅杰辉瑞公司(dug major Pfizer Inc.)的Hospira,Inc.正在召回部分批次的盐酸丁丙诺啡注射液和盐酸拉贝洛尔注射液。召回是由于可能存在不完整的卷曲密封而启动的。

The company has received one customer complaint for one leaking unit.The Buprenorphine HCl Injection is indicated for the management of pain requiring an opioid analgesic and for which alternate treatments are inadequate. The injection is a clear, sterile, injectable agonist-antagonist analgesic intended for intravenous or IV or intramuscular or IM administration.Labetalol HCl Injection is indicated for control of blood pressure in severe hypertension.The impacted products were distributed nationwide to wholesalers/hospitals in the U.S.

该公司已收到一个客户对一个泄漏装置的投诉。盐酸丁丙诺啡注射液用于治疗需要阿片类镇痛药且替代治疗不足的疼痛。该注射液是一种透明,无菌,可注射的激动剂-拮抗剂镇痛剂,用于静脉内或静脉内或肌肉内或IM给药。盐酸拉贝洛尔注射液适用于控制严重高血压患者的血压。受影响的产品在全国范围内分发给美国的批发商/医院。

from September 2023 through April 2024.If impacted products are administered to a patient, there is a potential for an increased risk of lack of therapeutic effect and systemic infection that may result in the need for additional medical treatment..

从2023年9月到2024年4月。如果给患者服用受影响的产品,则缺乏治疗效果和全身感染的风险可能会增加,这可能导致需要额外的治疗。。

So far, Pfizer has not received reports of any relevant adverse events associated with the issue for the recalled lots.The company urged wholesalers and hospitals with an existing inventory of any of the recalled lots to discontinue use, stop distribution, and quarantine the product immediately.Hospira in October last year had called back certain Sodium Bicarbonate and Lidocaine HCl Injections citing the potential for presence of glass particulate matter.For More Such Health News, visit rttnews.com For comments and feedback contact: editorial@rttnews.comHealth News.

到目前为止,辉瑞尚未收到与召回批次问题相关的任何相关不良事件的报告。该公司敦促拥有任何召回批次现有库存的批发商和医院停止使用,停止分销,并立即对产品进行检疫。Hospira在去年10月召回了某些碳酸氢钠和盐酸利多卡因注射液,理由是可能存在玻璃颗粒物质。有关更多此类健康新闻,请访问rttnews.com获取评论和反馈联系方式:editorial@rttnews.comHealth新闻。

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