FDA缬沙坦更新：MYLAN扩大召回 20181206

翻江鼠 · 发表于 2018-12-7 19:48:53

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Mylan expands its voluntary recall of valsartan-containing products

MYLAN扩大主动召回含缬沙坦药品

Update [12/6/2018] Mylan Pharmaceuticals is expanding its voluntary recall to include all lots of non-expired valsartan-containing products due to trace amounts of N-Nitrosodiethylamine (NDEA) in the valsartan active pharmaceutical ingredient (API) manufactured by Mylan Laboratories Limited. The 104 additional lots include 26 lots of amlodipine and valsartantablets, 51 lots of valsartan tablets and 27 lots of valsartan and hydrochlorothiazide tablets. These lots were distributed in the U.S. between March 2017 and November 2018.

更新时间【20181206】MYLAN药业目前扩大其主动召回至所有未过效期批次含缬沙坦药品，原因是在MYLAN生产的API中检出痕量NDEA。扩大召回增加了104个批次，其中26批阿莫洛地平缬沙坦片，51批缬沙坦片和27批缬沙坦氢氯噻嗪片。这些批次于201703至201811期间在美国销售。

The agency also updated the list of valsartan products under recall andthe list of valsartan products not under recall.

FDA已更新了其缬沙坦召回清单及未召回清单。

本文摘自Julia法规翻译

zysx01234 · 发表于 2018-12-7 20:13:13

难道是用华海的缬沙坦API生产的制剂

lszeric · 发表于 2018-12-7 21:35:18

zysx01234 发表于 2018-12-7 20:13
难道是用华海的缬沙坦API生产的制剂

valsartan active pharmaceutical ingredient (API) manufactured by Mylan Laboratories Limited.应该他们自己生产的

gproe · 发表于 2018-12-8 10:41:21

那肯定是NDEA超标了

xqliu · 发表于 2018-12-8 10:53:37

迈兰很积极呀

天下子 · 发表于 2018-12-8 11:56:03

问题是都存在的，华海只不过是问题引爆点罢了，华海的工艺应该是比较好的

无端锦瑟 · 发表于 2018-12-17 16:49:39

这么看华海果然不是独家有NDMA的~之前好像还有个印度公司爆出过

[FDA国外警告信] FDA缬沙坦更新：MYLAN扩大召回 20181206

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