Huahai issued two consecutive announcements to clarify that the NDEA content of losartan potassium recalled by Sandoz did not exceed the standard!
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Last Update: 2018-11-12
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Source: Internet
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Author: User
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Recently, suntex, a subsidiary of Novartis, announced in the announcement that it would recall a batch of losartan hydrochlorothiazide tablets in the United States due to the presence of NDEA impurities in the drug substance, and indicated that it was produced by Zhejiang Huahai In response, Huahai issued a Clarification Announcement on November 10 and a further progress announcement on November 12 According to the announcement, Huahai has tested more than 500 batches of samples produced by the company from 2016 to 2018 by using the validated GC-MS analysis and detection method, and the content is within the acceptable limit standard Moreover, the content of losartan potassium NDEA involved in this recall batch of Sandoz was detected to be 0.039ppm According to the standards of EU, US and Japan for the acceptable limit of losartan potassium NDEA, the content is far lower than the acceptable limit standard The specific announcement is as follows:
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