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本帖最后由 巴西木 于 2014-6-13 21:15 编辑
articles continue to cause major compliance problems and recalls 颗粒问题持续导致主要缺陷及引发召回 Again, a batch of sterile products has been recalled due to detected particles. In this case, the company Hospira has initiated a recall of the medicinal product "Labetalol Hydrochloride". Labetalol Hydrochloride a clear colourless solution for intravenous administration used in cases of severe blood pressure. The recall action concerns a lot with 20 mL multidose glass vials. The reason for that recall is "embedded particulate within the glass vial and visible particles floating in the solution". Investigations could identify the embedded particulate as stainless steal and the particles in the solution as iron oxide. The problems with the embedded particulate have been attributed to a supplier's glass defect. Because of the size of the particulates, "it is likely that particulates are able to pass through the catheter and may cause injection site reactions and local irritation in the blood vessels, tissues and organs". 一批无菌产品又一次因为检出颗粒物被召回。这次是由HOSPIRA公司对“盐酸拉贝洛尔”产品的召回。盐酸拉贝洛尔是一种用于静脉注射的澄清无色溶液,用于治疗高血压。所召回的是一批20ml多次给药剂型的玻璃瓶装药品。召回原因是“玻璃瓶有内嵌颗粒物,溶液中飘浮中可见颗粒物”。调查发现内嵌颗粒为不锈钢,溶液中飘浮物为氧化铁。内嵌颗粒的是由玻璃供应商的缺陷引起的。这些颗粒物的尺寸“可能会通过导管,引起注射点异常反应,静脉血管、组织和器官局部刺激”。
Actual health damages by the lot concerned aren't known. 该批次对人体的实际伤害情况尚不知晓。
You can find the report on the voluntary lot recall on the FDA website. 该批自愿召回的报告可以在FDA官网上找到。
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