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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
MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-pfizer-ltd-champix-all-strengths-film-coated-tablets-el-21-a-slash-25?utm_medium=email&utm_campaign=govuk-notifications&utm_source=97cdd42e-9465-4f68-a92e-8ad9b4d937f3&utm_content=immediately
CHAMPIX INITIAT 2 WEEK 0.5&1MG (25)
CHAMPIX MAINTENANCE 2 WEEK 1MG (28)
CHAMPIX MAINTENANCE 4 WEEK 1MG (56)
CHAMPIX INITIAT 4 WEEK 0.5&1MG (53)
CHAMPIX BOTTLE TAB 0.5MG (56)
Please note that we do not stock the PI Livery listed in the attached document from the MHRA and returns will not be accepted.
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.