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Drug substances with impurities are collected voluntarily

By Lee, Tak-Sun | translator Choi HeeYoung

21.09.14 12:08:10

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Some of the Irbesartan manufactured by Kukjeon and Pharmacostech are lot numbers

The MFDS said, "Drug substances without consumer recovery are excluded from the list of announcements on the 9th"


The recovery of antihypertensive drugs exceeding impurities is expanding. Following the Drug product, Drug substance began to recover. The MFDS announced on the 14th that it will voluntarily retrieve some of Kukjeon and Pharmacostech's Irbesartan's Drug Substance. Kukjeon and Pharmacostech start collecting four manufacturing number products each.

Following the drug product, the recovery of drug substances began. Initially, the MFDS announced on the 9th that it would voluntarily recover 73 items from 36 companies that manufacture Sartan hypertension treatments (1.51 to 7.677/day) exceeding the daily intake of AZBT, which is an impurity. All of these items are Drug products, and only manufacturing number

Lee, Tak-Sun(hooggasi2@dailypharm.com)
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