部分氢吗啡酮和异丙酚注射剂因包装问题被召回

圣路易斯(MD Consult)——2012年8月14~15日，Hospira公司宣布正在召回2种注射剂产品，涉及3个批次(批号07-893-DJ，有效期至2013年7月1日；批号10-123-DJ，有效期至2013年10月1日；批号10-125-DJ，有效期至2013年10月1日)的异丙酚乳剂(1%，1g/100 mL)，原因是玻璃瓶内嵌入了一些可见颗粒物；1个批次(批号12720LL，有效期至2013年12月1日)的氢吗啡酮注射剂，剂量规格为2 mg/ml，以1 ml预装于2.5 ml Carpujects注射器中，召回原因是实际药液体积可能超过了1 ml预装规格。

就异丙酚召回而言，药液有可能接触到玻璃瓶内嵌入的颗粒物，颗粒物有可能脱落到药液中。如果将颗粒物注射到患者体内，则有可能对患者造成损伤，可能需要医疗干预。与这一产品缺陷相关的风险包括1个或多个器官组织坏死，从而可能导致卒中、心肌梗死、呼吸衰竭以及肝肾功能受损。

Hospira目前尚未收到任何与所召回批次异丙酚产品相关的不良事件报告。公司已经着手调查此事的根本原因，并采取相应的整改及防范措施。调查的初步结果显示，问题的根源在于供应商提供的玻璃瓶存在缺陷。目前这家玻璃瓶供应商也在配合Hospira 的工作以明确导致该缺陷的原因。

就氢吗啡酮召回而言，Hospira已经收到了1份关于Carpuject注射器内所含药液超过1 ml预装规格的投诉。氢吗啡酮等阿片类镇痛药使用过量可能导致危及生命的严重后果，包括呼吸抑制、低血压和心动过缓，从而引发循环衰竭。

Hospira目前尚未收到任何与所召回批次氢吗啡酮产品相关的不良事件报告。公司现已完成了对事故原因的调查，并且采取了相应的防范措施以免这类事故重演。

与使用召回产品相关的不良反应可以直接上报至FDA的MedWatch不良事件报告系统。

爱思唯尔版权所有  未经授权请勿转载

ST LOUIS (MD Consult) - On August 14 and August 15, 2012, Hospira announced that it is conducting recalls of 2 of their injectable products. Three lots (lot# 07-893-DJ, expiration July 1, 2013; lot# 10-123-DJ, expiration October 1, 2013; and lot# 10-125-DJ, expiration October 1, 2013) of propofol emulsion 1% in 1-g/100 mL vials are being recalled because of the presence of visible particles embedded in the glass containers. In addition, 1 lot (lot# 12720LL, expiration December 1, 2013) of hydromorphone 2 mg/mL, 1-mL fill packaged in 2.5-mL Carpujects is being recalled because a potential exists that the prefilled syringes may be overfilled beyond the 1-mL labeled fill volume.

In regard to the propofol recall, a potential exists for product to come in contact with the embedded particles in the vials, and the particles may become dislodged into the solution. In the event in which particulate matter could be injected into a patient, a potential exists for patient injury where medical intervention may be required. Risks associated with this defect could include tissue necrosis in one or more organs that could result in stroke, myocardial infarction, respiratory failure, and the loss of renal and hepatic function.

Hospira has not received any reports of adverse events related to the recalled lots of propofol. The company has initiated an investigation to determine root cause and corrective and preventive measures. The investigation has preliminarily identified the root cause as a supplier glass defect. Hospira is working with its glass vial supplier to determine the cause of the defect.

In regard to the hydromorphone recall, Hospira has received a complaint of a single Carpuject containing more than the 1 mL labeled fill volume. An overdose of opioid pain medications such as hydromorphone may lead to life-threatening consequences. Those consequences can include respiratory depression, hypotension, and bradycardia which can lead to circulatory collapse.

Hospira has not received any reports of adverse events related to this issue for the recalled lot of hydromorphone. The company has completed an investigation to determine the root cause and has put measures in place to prevent recurrence.

Adverse reactions experienced with the use of the recalled products may be reported to the FDA's MedWatch Adverse Event Reporting Program.