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Will impurities again in losartan trigger full recalls?

By Lee, Tak-Sun | translator Alice Kang

21.11.17 06:18:15

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Industry¡°Impurities were detected in active substances of many generics¡±¡¦ lot releases being discontinued successively

Companies will submit self-inspection results to MFDS by end of the month¡¦some have requested deadline extensions


Once again, impurity was detected in ¡®losartan,¡¯ an ingredient used in hypertension treatments. The impurity in issue was detected during self-inspections conducted by the individual pharmaceutical companies under the direction of the Ministry of Food and Drug Safety, upon which some companies have been discontinuing the lot release of their products.

In particular, the companies are concerned that a large number of the drugs will be subject to recall, as they believe the raw materials imported from India and China that are used by most generic companies may be the cause of the problem. The MFDS plans to take additional measures after receiving the companys¡¯ test results by the end of this month.
Lee, Tak-Sun(hooggasi2@dailypharm.com)
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