Pentec Health主动召回部分无菌透析产品

圣路易斯(MD Consult)——2013年5月17日，美国食品药品管理局(FDA)宣布，Pentec Health正在主动召回已被处方给163例肾脏透析患者的特定药物。之所以发起本次召回，是因为该公司在合成药物时使用的1个层流净化罩不能保证完全无菌。Pentec Health尚未接获任何与应召回产品相关的损伤或疾病报告。

Pentec Health正在直接通知受到波及的每家透析中心和每例家中透析患者。本次召回涉及在2013年5月2日当天或之前在这一净化罩中合成的透析治疗产品。针对这一净化罩以及在其中合成的终产物的检查均得出了无菌的结果。

应将与使用应召回产品相关的不良事件报告至FDA的MedWatch不良事件报告系统。

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ST LOUIS (MD Consult) - On May 17, 2013, the US Food and Drug Administration (FDA) announced that Pentec Health is conducting a limited, voluntary recall of certain therapies that have been prescribed for a total of 163 patients undergoing renal dialysis. The recall is occurring because a lack of sterility assurance exists in one of the company's laminar flow hoods used in compounding. Pentec Health has received no reports of injury or illness associated with any of the prescriptions subject to this recall.

Pentec Health is directly notifying each involved dialysis center and in-home dialysis patient of the recall. The recall covers renal therapies that were compounded in this hood on or before May 2, 2013. Sterility tests associated with the compounding hood involved, as well as testing of finished products made in the hood, have shown sterility.

Adverse events related to use of the recalled products should be reported to the FDA's MedWatch Adverse Event Reporting Program.