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 expla