Class 2 Medicines Recall: Pfizer Ltd, Champix (all strengths) film-coated tablets, EL (21)A/25

Medicines Healthcare Products Regulatory Agency

October 14
12:58 2021

Company name

Pfizer Limited

Product Name

  • Champix 0.5mg film-coated tablets, PLGB 00057/1554
  • Champix 0.5mg + 1mg film coated tablets, PLGB 00057/1555
  • Champix 1mg film-coated tablets, PLGB 00057/1556

For batch numbers, please see here.

Active Pharmaceutical Ingredients: Varenicline Tartrate

MDR number

MDR 062-06/21

Brief description of the problem

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.

Advice for healthcare professionals

  • Please quarantine all remaining stock of the specified batches and return them to your supplier using your suppliers approved process.
  • Healthcare professionals should advise patients undergoing treatment to discuss any questions or concerns with their prescribing healthcare professional.

See additional advice from the Department of Health and Social Care

(Link to Supply Disruption Alert)

  • Patients currently prescribed this treatment will require review and switching to nicotine replacement therapy (NRT) unless contraindicated.
  • No new patients should be initiated on Champix (varenicline) products.
  • Prescribers initiating smoking cessation treatment for new patients should consider prescribing NRT or bupropion 150mg prolonged release tablets unless contraindicated.
  • Helping a patient to stop smoking should not be delayed if they are motivated to stop as other effective options are available.

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.

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists, GPs and dispensing general practitioners for information.

Parallel Import/Distributed products:

There are specified batches in the recall of Champix 1mg Film-Coated Tablets released for sale in the EU under the Marketing Authorisation of Pfizer Europe MA EEIG and parallel distributed by Drugsrus Limited and repackaged by P.I.E Pharma Ltd. For more information, please contact: Drugsrus Limited, providing the batch number of the stock and the name of the parallel distributor on the over label on the pack.

  • Champix 1mg Film-Coated Tablets, EU/1/06/360/015, EU/1/06/360/016

For batch numbers, please see here.

Active Pharmaceutical Ingredient: Varenicline Tartrate

Download document

Class 2 Medicines Recall: Pfizer Ltd, Champix (all strengths) film-coated tablets, EL (21)A/25

Please also see the Direct Healthcare Professional Letter below for further guidance:

Pfizer CHAMPIX DHPC October 2021

Published 14 October 2021

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