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Three further Losartan batches recalled

三批氯沙坦被召回

The MHRA has recalled three batches of Losartan tablets due to contamination with the nitrosamine N-nitroso-N-methylamino butyric acid… 

MHRA已经召回了三批氯沙坦片，原因是它们被亚硝胺n -亚硝基-n -甲氨基丁酸污染。

As a precautionary measureto protect public health, the Medicines and Healthcare products Regulatory Agency (MHRA) has recalled three batches of Losartan tablets due to contamination with the nitrosamineN-nitroso-N-methylamino butyric acid (NMBA). These are the affected batches.

为保障公众健康，美国药品及保健品监管局(MHRA)已召回三批氯沙坦片，原因是这些药片含有亚硝胺n -亚硝基-n -甲氨基丁酸(NMBA)。这些是受影响的批次。

Therecall is taking place as part of the continued investigation into potentialnitrosamine contamination of sartan containing medicines, a class of medicine to treat blood pressure and heart attacks and heart failures.

此次药物回收是对含沙坦的药物可能受到亚硝胺污染的持续调查的一部分。沙坦是一种治疗血压、心脏病发作和心力衰竭的药物。

Currently there is no evidence that nitrosamine impurities can cause harm and patients are being advised to continue taking their medication.

目前没有证据表明亚硝胺杂质会造成伤害，建议患者继续服用。

The investigation into possible contamination of sartan medicines began in 2018, after the nitrosamine N-nitrosodimethylamine (NDMA), was identified invalsartan manufactured at a facility based in China.

在中国一家工厂生产的缬沙坦中发现亚硝胺n -亚硝基二甲胺(NDMA)后，于2018年开始对可能存在的沙坦药物污染进行调查。

In 2018 the MHRA recalledbatches of valsartan containing tablets to pharmacy level in July and November due topossible NDMA and N-nitrosodiethylamine (NDEA) contamination.

In January and February 2019 the MHRAre called batches of irbesartan containing tablets after testing revealed possible contamination with NDEA.

2018年，MHRA在7月和11月召回了一批含有缬沙坦药片的批次，原因是可能存在NDMA和n -亚硝基二乙胺(NDEA)污染。

2019年1月和2月，MHRA召回了几批含有厄贝沙坦的药片，此前测试显示这些药片可能受到了NDEA的污染。

The MHRA continues to monitor the situation in the UK and are comprehensively investigating the issuea longside the European Medicines Agency (EMA)and the European Directorate for the Quality of Medicines (EDQM).

MHRA继续监测英国的情况，并与欧洲药品管理局(EMA)和欧洲药品质量理事会(EDQM)一起全面调查这一问题。

Bernadette Sinclair-Jenkins, MHRA’s Manager, Regulatory Assessment Unit of the Inspection, Enforcement and Standards Division, said “There is no evidence at present that medicines containing NDMA, NDEA or NMBA have caused any harm to patients and this recall is a precautionary measure.”

MHRA检查、执法和标准部门监管评估部门经理伯纳黛特•辛克莱尔-詹金斯(Bernadette Sinclair-Jenkins)表示:“目前没有证据表明，含有NDMA、NDEA或NMBA的药物对患者造成了任何伤害，此次召回是一项预防措施。

Source: EPR – European Pharmaceutical Review

本文内容取自 EPR

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