Class 2 Recall
Champix (varenicline tartrate) is indicated for smoking cessation in adults. Upon request from MHRA, Pfizer Ltd are recalling specified batches (all stock) of products as a precautionary measure due to presence of levels of N-nitroso-varenicline above the acceptable level of intake set by both European Medicines Agency (EMA) and MHRA. The recall is at pharmacy and wholesaler level
PIP CODE | DESCRIPTION | SUPPLIER | AFFECTED BATCHES |
3252749 | CHAMPIX INITIAT 2 WEEK 0.5&1MG (25) | PFIZER LTD | 00021535 DP3142 EH7896 DT1144 DM0273 |
3252731 | CHAMPIX MAINTENANCE 2 WEEK 1MG (28) | PFIZER LTD | 00022123 ED8501 ED8498 DX4579 DH2706 DK4800 DK4802 DL0986 DL0987 DL0988 DR4333 DR4334 ED8500 |
3271442 | CHAMPIX MAINTENANCE 4 WEEK 1MG (56) | PFIZER LTD | 00021134 00021135 EH5976 DH2705 DR1612 EA6772 |
3997418 | CHAMPIX INITIAT 4 WEEK 0.5&1MG (53) | PFIZER LTD | EM4806 EA6793 DT1145 00020444 00022138 |
3252723 | CHAMPIX BOTTLE TAB 0.5MG (56) | PFIZER LTD | EX5767 DY1653 |
Please note that we do not stock the PI Livery listed in the attached document from the MHRA and returns will not be accepted.
Further Information
Pfizer is aware of the current supply constraints related to this product and is working to resolve the issue and resume manufacturing. Further updates relating to potential resupply will be communicated in due course.
If you have any questions, then please contact your local Service Centre Customer Services team.
For medical information enquiries, please contact Pfizer Medical Information Department on 01304 616161.
Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.
Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.