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Clopidogrel recall due to 1 CMO¡¦¡¯no issue escalation¡¯

By Lee, Hye-Kyung | translator Kim, Jung-Ju

24.04.09 05:50:45

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MFDS discovered the issue during the post-marketing safety test

Companies already changed to in-house manufacturing or switched contract manufacturers


The issue that stirred up the clopidogrel recall that had been ongoing since March was found to have been caused by a single contract manufacturer, making the concern of it escalating to a series of recalls unlikely.

Starting with Daewoong Bio's 'Clovons Tab' on March 17, the Ministry of Food and Drug Safety recalled a total of 29 items from 27 companies by April 2.

The MFDS¡¯s reason for the recall is 'exceeding the standard for miscellaneous related impurities during post-marketing stability tests'.

In the case of marketed drugs, stability tests are required to be conducted annually for all dosage forms, on at least one manufacturing lot each per packaging type that cont

Lee, Hye-Kyung(hgrace7@dailypharm.com)
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