Pfizer voluntarily recalls Champix 10 days after MFDS annc.

Recalls products that exceed the temporary lot release standard

The products were not subject to recall on the 7th... settling controversy over fairness of its standards

Some lots of Pfizer’s leading smoking cessation treatment, Champix, will be voluntarily recalled.

 

Although the drugs were not subject to recall under the MFDS announcement on the 7th, Pfizer opted to voluntarily recall its products as the drugs exceeded the MFDS's temporary release standards.

 

The standards that the company applied for recall were stricter than the initial recall standards set by the Ministry of Food and Drug Safety that had raised controversy over how the initial standards were set.

 

On the 17, the MFDS announced that 9 lots of Pfizer Korea's ‘Champix 1mg (varenicline tartrate)’ will be voluntarily recalled by its seller.

 

The lot numbers of the recalled products are 00026756, 00025815, 00025121, 00024632, 00024054, 00022720, 00021762, 00021761, and 00022721.

 

The above products were manufactured from May 2019 to December of last year.

 

As for the reason for the recall, the company wrote that the move was a ‘voluntary recall for products exceeding the temporary lot release standards of NNV (N-nitroso-varenicline).’ The said products were not subject to recall under the NNV safety investigation results that were announced by MFDS on the 7th.

 

At the time, the MFDS explained that drugs with NNV exceeding 733 ng/day were to be voluntarily recalled.

 

Based on the standards, Pfizer’s Champix, with NNV 151~632ng/day detected, was not subject to recall.

 

However, Pfizer belatedly started to recall its product based on the temporary release standard at 185 ng/day rather than the recall standard.

 

MFDS investigation data regarding safety of NNV containing varenicline that was announced on the 7th

Controversy had arose as the NNV level of 733ng/day that was set for voluntary recall by the MFDS was based on Pfizer’s standards.

 

The minutes of the Central Pharmaceutical Affairs Council that was disclosed on the webpage on the 17th stated that Pfizer's standards were inevitably applied for the recall.

 

The minutes showed that CPAC had decided to maintain the voluntary recall standard at NNV of 733ng/day as set by Pfizer.

 

However, as the standards set by Pfizer exclude Pfizer’s Champix from recalls, controversy arose as to whether the measures were unfairly supporting a specific company.

 

Pfizer's decision to recall its products based on the temporary release standards (185ng/day), settled the controversy over the fairness of CPAC’s standards.

 

However still, the fact that the authorities had decided to manage NNV impurities with different standards set for lot release and recall is still expected to raise some eyebrows.