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  • 3 companies voluntarily recall varenicline products
  • by Lee, Jeong-Hwan | translator Alice Kang | Sep 8, 2021 06:05am
that contain impurities that exceed the limit set by MFDS
19 lot release numbers from CTC Bio are recalled¡¦includes Vivozone and Hanmi's products
MFDS plans to publicly announce the safety investigation results¡¦ the acceptable amount of daily intake for NNV is ¡®37ng¡¯

Results of the safety investigation conducted by the Ministry of Food and Drug Safety on the N-nitroso-varenicline (NNV) impurity that was found in the smoking-cessation aid varenicline showed that the impurity¡¯s risk of harming the human body was very low.

However, all drugs that contain over ¡®733ng (nanograms)/day¡¯ of NNV will be voluntarily recalled by the companies in line with the standards set by the U.S regulators,

Varenicline products that will be voluntarily recalled include those manufactured (consigned products included) by CTC Bio, and consists of 2 lots of Zerocotine tab. from Vivozone, 2 lots of Nicobreak tab. from CTC Bio, and 15 lot of Nokotine S from Hanmi Pharmaceutical.

The MFDS ann
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