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