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CLASS 2 RECALL - CHAMPIX (ALL STRENGTHS) FILM-COATED TABLETS

Recalls and Alerts

Class 2 Recall

CLASS 2 RECALL - CHAMPIX (ALL STRENGTHS) FILM-COATED TABLETS

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   

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.