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  • Varenicline recalls were based on Pfizer's standards
  • by Lee, Tak-Sun | translator Alice Kang | Sep 23, 2021 05:43am
based on which Pfizer was able to avoid recalls
MFDS had set different standards for lot release and recall on the 7th
CPAC inevitably applied Pfizer's standards for the recall due to concern over patient treatment and supply shortage

On why the recall and lot release standards were set differently for the smoking cessation treatment ¡®varenicline,¡¯ which was found to have nitrosamine impurities, is gaining attention. This difference in standards had allowed Pfizer¡¯s Champix from being recalled.

While announcing the N-nitroso-varenicline (NNV) impurity test results on varenicline products on the 7th, the Ministry of Food and Drug Safety announced that products with less than 185ng/day of NNV may temporarily be approved for lot release.

On the other hand, products with NNV of 733ng/day or more were to be voluntarily recalled by their manufacturers.

Regarding the set standards, the MFDS had explained that it had referenced cases from oth
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