Class 2 Medicines Recall: Champix (all strengths) film-coated tablets (Pfizer Ltd)

Class 2 Medicines Recall: Champix (all strengths) film-coated tablets (Pfizer Ltd)

October 14, 2021

Drug alert number: EL (21)A/25

MDR Number: MDR 062-06/21

Date issued: 14th October 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 medicines recall for Champix (all strengths) film-coated tablets (Pfizer Ltd)

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.

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

Batch Number Expiry Date Pack Size First Distributed
EX5767 31 Dec 2022 Champix 0.5mg 1×56 13 May 2021
DY1653 31 May 2022 Champix 0.5mg 1×56 20 Nov 2020
00022123 31 Aug 2022 Champix maintenance 2-week 1mg 03 Jan 2020
ED8501 31 Oct 2022 Champix maintenance 2-week 1mg 13 May 2021
ED8498 31 Oct 2022 Champix maintenance 2-week 1mg 08 Apr 2021
DX4579 31 Oct 2022 Champix maintenance 2-week 1mg 17 Dec 2020
DH2706 31 Jul 2022 Champix maintenance 2-week 1mg 31 Mar 2020
DK4800 31 Jul 2022 Champix maintenance 2-week 1mg 31 Mar 2020
DK4802 30 Jun 2022 Champix maintenance 2-week 1mg 31 Mar 2020
DL0986 31 Aug 2022 Champix maintenance 2-week 1mg 31 Mar 2020
DL0987 31 Aug 2022 Champix maintenance 2-week 1mg 14 Apr 2020
DL0988 31 Aug 2022 Champix maintenance 2-week 1mg 19 May 2020
DR4333 31 Oct 2022 Champix maintenance 2-week 1mg 29 May 2020
DR4334 31 Oct 2022 Champix maintenance 2-week 1mg 01 Oct 2020
ED8500 31 Oct 2022 Champix maintenance 2-week 1mg 11 May 2021
00021535 30 Jun 2022 Champix initiation 2 week 0.5&1mg 21 Jan 2020
DP3142 30 Nov 2022 Champix initiation 2 week 0.5&1mg 06 Aug 2020
EH7896 31 Dec 2022 Champix initiation 2 week 0.5&1mg 06 Apr 2021
DT1144 30 Nov 2022 Champix initiation 2 week 0.5&1mg 27 Oct 2020
DM0273 30 Nov 2022 Champix initiation 2 week 0.5&1mg 28 May 2020
00021134 31 May 2022 Champix maintenance 4-week 1mg 13 Nov 2019
00021135 30 Apr 2022 Champix maintenance 4-week 1mg 30 Oct 2019
EH5976 28 Feb 2023 Champix maintenance 4-week 1mg 19 Jan 2021
DH2705 30 Jun 2022 Champix maintenance 4-week 1mg 13 Mar 2020
DR1612 31 Oct 2022 Champix maintenance 4-week 1mg 21 May 2020
EA6772 31 Oct 2022 Champix maintenance 4-week 1mg 17 Sep 2020
EM4806 30 Nov 2022 Champix initiation 4 week 0.5&1mg 06 Apr 2021
EA6793 30 Nov 2022 Champix initiation 4 week 0.5&1mg 17 Dec 2020
DT1145 30 Nov 2022 Champix initiation 4 week 0.5&1mg 10 Jul 2020
00020444 31 Jan 2022 Champix initiation 4 week 0.5&1mg 02 Sep 2019
00022138 31 Mar 2022 Champix initiation 4 week 0.5&1mg 03 Jan 2021

Parallel Import/Distributed products

The below batches 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 recall@drugsrus.co.uk, 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

Batch Number Expiry Date Pack Size First Distributed
Job Number: J/262
Batch Number: DR2392
07/2022 28 09/07/2020
Job Number: J/263
Batch Number: DR2391
07/2022 28 27/06/2020
Job Number: J/546
Batch Number: DR2392
07/2022 28 28/07/2020
Job Number: L/090
Batch Number: DR2392
07/2022 28 16/04/2021
Job Number: L/091
Batch Number: DR2391
07/2022 28 16/04/2021
Job Number: L/092 or L799
Batch Number: DR1762
10/2022 28 16/04/2021
Job Number: J/245
Batch Number: DK4770
07/2022 28 12/08/2020
Job Number: J/246
Batch Number: DH2704
07/2022 28 27/06/2020
Job Number: L/800
Batch Number: EC8473
10/2022 28 22/01/2020
Job Number: J/328 or J/547 or J/997
Batch Number: DR1611
10/2022 28 22/09/2020

Advice for healthcare professionals

  • Please quarantine all remaining stock of the above batches and return them to your supplier using your supplier’s 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 (see 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.

View alert here.

 



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