FMD Alert: Class 2 (EL (19)A/19)
Medicines have been taken out of the regulated medicines’ supply chain during distribution. The products have been parallel imported into the UK by Kosei Pharma, CST Pharma and Ordinant Medical Solutions from Italy and they have been re-labelled in Kosei Pharma UK Ltd, MPT Pharma Ltd, Drugsrus Ltd / P.I.E. Pharma Ltd and Doncaster Pharmaceuticals Group Ltd livery.
Kosei Pharma UK Ltd
Please see Appendix 1 for list of products and batch numbers
MPT Pharma Ltd
Please see Appendix 2 for list of products and batch numbers.
Doncaster Pharmaceuticals Group Ltd
Please see Appendix 3 for list of products and batch numbers.
Drugsrus Ltd / P.I.E. Pharma Ltd
Please see Appendix 4 for list of products and batch numbers.
Brief details of issue:
It has come to our attention that these medicines have been taken out of the regulated medicines' supply chain during distribution and later re-introduced. This means that the correct transport and storage conditions cannot be guaranteed during this period and, whilst unlikely, could impact their effectiveness. The products are believed to be legitimate. There is no evidence that they have been tampered with and these medicines are stable at room temperature.
Following the issue of FMD Alert EL (19)A/15 on 27 June 2019, we have become aware that Kosei Pharma UK Ltd, CST Pharma Ltd and Ordinant Medical Solutions Ltd have also parallel imported some affected products into the UK from Italy and they have been re-labelled in Kosei Pharma UK Ltd, MPT Pharma Ltd, Drugsrus Ltd / P.I.E. Pharma Ltd and Doncaster Pharmaceuticals Group Ltd livery.
Advice for healthcare professionals:
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Please check your stock of all listed products for the relevant products in Kosei Pharma UK Ltd, MPT Pharma Ltd, Drugsrus Ltd / P.I.E. Pharma Ltd and Doncaster Pharmaceuticals Group Ltd livery. If any relevant packs are identified, please quarantine and return to your supplier using your supplier's approved process.
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The MHRA has undertaken a medical assessment to determine whether there is any risk to patients. As a precautionary measure, two medicines are being recalled to patient level because in the very unlikely event that these medicines are not fully effective there is a potential risk to patient safety. For these two particular medicines, whilst the likelihood of their effectiveness being compromised is low (because they are stable legitimate medicines), the consequences of a lack of effectiveness could be serious which is why we are treating them differently. If patients have either of these affected products, you should advise that they continue taking their medicines and contact their GP practice to arrange a new prescription. Once they have a new prescription, patients should return the affected batches to their pharmacist.
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The products being recalled to patient level are Neupro 4mg/24hr patches and Vimpat 100mg tablets. We will use media, social media and will contact patient groups and charities to help draw the attention of patients to the affected batches of these products.
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As a precaution, all other affected medicines are being recalled at pharmacy level. Again, you should advise patients to continue taking their medicines. If they have any of these affected medicines, they do not need to arrange a new prescription but if they have any questions, they should speak to their GP or healthcare professional. The products being recalled at pharmacy level are: Dovobet Gel, DuoResp Spiromax 160mcg / 4.5mcg Inhaler, Incruse Ellipta 55mcg Inhaler, Seretide Evohaler 250mcg and Spiriva 18mcg Inhalation Powder Capsules.
Contacts for further Information:
Kosei Pharma UK Ltd:
For general enquiries, please contact Mr. Saket Jadhav Tel: 01753515054,
Email: saket.j@koseipharma.com
For medical information enquiries, please contact Mr. Kalpesh Patel Tel: 01753515050
Email: Kalpeshkumar.p@koseipharma.com
MPT Pharma Ltd:
For all enquiries please email productrecalls@mptpharma.co.uk
Doncaster Pharmaceuticals Group Ltd:
For all enquiries, please contact:
Rachael Hill, Email: rachael.hill@doncaster-pharm.com Tel 01302 554804
or
Richard Gore, Email: richard.gore@doncaster-pharm.com Tel: 01302 554805
Drugsrus Ltd / P.I.E. Pharma Ltd:
For all enquiries, please contact:
Drugsrus Customer Services, Email: recall@drugsrus.co.uk Tel: 020 8423 3800
Recipients of this Alert should bring it to the attention of relevant contacts by copy of this letter. NHS Regional teams are asked to forward this to relevant clinics, general practitioners and community pharmacists.
*Falsified Medicines Directive Alert
Falsified Medicines Directive (FMD) 2011/62/EU introduced new requirements to enhance the security of the European supply chain. Where the MHRA has identified risks to the security of the supply chain, FMD Alerts will be issued.
For further information about FMD and safety features, please see this link on GOV.UK.
Appendix 1: Table of Products / Batches Kosei Pharma UK Ltd
| Products and Pack Size** ** | ** Italian Batch Number ** | ** Kosei Batch Number ** | ** Expiry Date ** | ** Date of First Distribution** |
|---|---|---|---|---|
| DOVOBET GEL 2 X 30G | A54603 | A54603/1 | Jul-19 | 07/12/2017 |
| DOVOBET GEL 2 X 30G | A54603 | A54603/4 | Jul-19 | 11/01/2018 |
| DOVOBET GEL 2 X 30G | A57133 | A57133/3 | Aug-19 | 11/01/2018 |
| DOVOBET GEL 2 X 30G | A57134 | A57134/4 | Aug-19 | 11/01/2018 |
| DOVOBET GEL 2 X 30G | A58906 | A58906/1 | Sep-19 | 11/01/2018 |
| DOVOBET GEL 2 X 30G | A74927 | A74927/2 | Apr-20 | 22/08/2018 |
| DOVOBET GEL 2 X 30G | A77417 | A77417/6 | May-20 | 15/11/2018 |
| DOVOBET GEL 2 X 30G | A78018 | A78018/2 | May-20 | 15/11/2018 |
| DOVOBET GEL 2 X 30G | A79684 | A79684/1 | Jun-20 | 14/11/2018 |
| DOVOBET GEL 2 X 30G | A79729 | A79729/2 | Jun-20 | 15/11/2018 |
| DOVOBET GEL 2 X 30G | A83364 | A83364/2 | Aug-20 | 31/01/2019 |
| DOVOBET GEL 2 X 30G | A85747 | A85747/2 | Oct-20 | 31/01/2019 |
| DOVOBET GEL 2 X 30G | A85936 | A85936/1 | Oct-20 | 31/01/2019 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R834141 | R834141/1 | Sep-19 | 22/08/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R838744 | R838744/1 | Oct-19 | 17/05/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R838744 | R838744/2 | Oct-19 | 15/10/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R839098 | R839098/1 | Oct-19 | 18/07/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R842742 | R842742/1 | Jan-20 | 17/05/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R842742 | R842742/2 | Jan-20 | 06/06/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R842742 | R842742/3 | Jan-20 | 22/08/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R842742 | R842742/4 | Jan-20 | 15/10/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R842742 | R842742/5 | Jan-20 | 01/02/2019 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R844186 | R844186/1 | Dec-19 | 17/05/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R844186 | R844186/2 | Dec-19 | 06/06/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R844186 | R844186/3 | Dec-19 | 22/08/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R844186 | R844186/4 | Dec-19 | 26/10/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R846745 | R846745/2 | Jan-20 | 22/08/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R846745 | R846745/3 | Jan-20 | 26/10/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R848815 | R848815/2 | Feb-20 | 22/08/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R848815 | R848815/3 | Feb-20 | 15/10/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R848815 | R848815/4 | Feb-20 | 26/10/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R849465 | R849465/2 | Feb-20 | 22/08/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R849465 | R849465/3 | Feb-20 | 15/10/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R849465 | R849465/4 | Feb-20 | 26/10/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R851918 | R851918/2 | Mar-20 | 09/10/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R851918 | R851918/3 | Mar-20 | 26/10/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R853231 | R853231/1 | Mar-20 | 15/10/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R853231 | R853231/2 | Mar-20 | 26/10/2018 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R856773 | R856773/1 | Jul-20 | 01/02/2019 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R858970 | R858970/1 | Aug-20 | 05/02/2019 |
| INCRUSE ELLIPTA 55MCG INHALER 1 X 30 DOSES | R860226 | R860226/1 | Aug-20 | 01/02/2019 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56659401 | 56659401/7 | Oct-19 | 28/02/2019 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56659403 | 56659403/5 | Oct-19 | 23/05/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56666402 | 56666402/9 | Nov-19 | 09/03/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56666402 | 56666402/12 | Nov-19 | 23/05/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56666403 | 56666403/1 | Nov-19 | 09/03/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56670401 | 56670401/2 | Dec-19 | 01/03/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56670401 | 56670401/8 | Dec-19 | 23/05/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56670401 | 56670401/9 | Dec-19 | 14/06/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56670401 | 56670401/11 | Dec-19 | 26/09/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56679402 | 56679402/1 | Jan-20 | 14/03/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56679402 | 56679402/9 | Jan-20 | 13/07/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56679402 | 56679402/11 | Jan-20 | 22/01/2019 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56688403 | 56688403/4 | Feb-20 | 23/05/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56688403 | 56688403/7 | Feb-20 | 28/08/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56688403 | 56688403/11 | Feb-20 | 22/10/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56688403 | 56688403/15 | Feb-20 | 22/10/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56695404 | 56695404/1 | Mar-20 | 24/05/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56695404 | 56695404/3 | Mar-20 | 11/06/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56695404 | 56695404/5 | Mar-20 | 12/06/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56695404 | 56695404/8 | Mar-20 | 22/10/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56695404 | 56695404/13 | Mar-20 | 22/10/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56699404 | 56699404/1 | Apr-20 | 14/06/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56699404 | 56699404/2 | Apr-20 | 22/10/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56699404 | 56699404/5 | Apr-20 | 21/11/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56699404 | 56699404/8 | Apr-20 | 31/12/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56699404 | 56699404/15 | Apr-20 | 31/12/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56699404 | 56699404/16 | Apr-20 | 31/12/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56712403 | 56712403/1 | Jun-20 | 31/12/2018 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56712403 | 56712403/2 | Jun-20 | 21/01/2019 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56712403 | 56712403/4 | Jun-20 | 18/02/2019 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56712404 | 56712404/1 | Jun-20 | 10/01/2019 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56712404 | 56712404/2 | Jun-20 | 24/01/2019 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56712404 | 56712404/4 | Jun-20 | 18/02/2019 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56722401 | 56722401/1 | Jul-20 | 18/02/2019 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56728403 | 56728403/1 | Aug-20 | 18/02/2019 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56728403 | 56728403/4 | Aug-20 | 18/02/2019 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56737110 | 56737110/1 | Sep-20 | 25/02/2019 |
| NEUPRO 4MG/24HR TRANDERMAL PATCHES 1 X 28 | 56742401 | 56742401/2 | Nov-20 | 28/02/2019 |
| SERETIDE EVOHALER 250MCG 1 X 120 DOSES | K62W | K62W/3 | Aug-19 | 09/02/2018 |
| SPIRIVA 18MCG INHALATION POWDER CAPSULES 1 X30 | 705605 | 705605/11 | Jul-19 | 05/06/2018 |
| SPIRIVA 18MCG INHALATION POWDER CAPSULES 1 X30 | 706803 | 706803/5 | Sep-19 | 29/05/2018 |
| SPIRIVA 18MCG INHALATION POWDER CAPSULES 1 X30 | 706803 | 706803/7 | Sep-19 | 07/06/2018 |
| SPIRIVA 18MCG INHALATION POWDER CAPSULES 1 X30 | 706803 | 706803/13 | Sep-19 | 19/07/2018 |
| SPIRIVA 18MCG INHALATION POWDER CAPSULES 1 X30 | 801497 | 801497/2 | Jan-20 | 13/07/2018 |
| SPIRIVA 18MCG INHALATION POWDER CAPSULES 1 X30 | 801497 | 801497/5 | Jan-20 | 13/08/2018 |
| SPIRIVA 18MCG INHALATION POWDER CAPSULES 1 X30 | 801497 | 801497/6 | Jan-20 | 13/08/2018 |
| SPIRIVA 18MCG INHALATION POWDER CAPSULES 1 X30 | 801500 | 801500/2 | Jan-20 | 08/08/2018 |
| SPIRIVA 18MCG INHALATION POWDER CAPSULES 1 X30 | 801932 | 801932/2 | Feb-20 | 14/06/2018 |
| SPIRIVA 18MCG INHALATION POWDER CAPSULES 1 X30 | 801932 | 801932/6 | Feb-20 | 17/07/2018 |
| SPIRIVA 18MCG INHALATION POWDER CAPSULES 1 X30 | 801932 | 801932/11 | Feb-20 | 13/08/2018 |
| VIMPAT 100 MG TABLETS 1 X 56 | 248884 | 248884/11 | Dec-22 | 05/02/2019 |
| VIMPAT 100 MG TABLETS 1 X 56 | 252026 | 252026/5 | Jan-23 | 05/02/2019 |
| VIMPAT 100 MG TABLETS 1 X 56 | 254265 | 254265/4 | Apr-23 | 20/02/2019 |
| VIMPAT 100 MG TABLETS 1 X 56 | 255279 | 255279/1 | Apr-23 | 20/02/2019 |
Appendix 2: Table of Products / Batches MPT Pharma Ltd
| Products and Pack size | Italian Batch Number | MPT Batch Number | Expiry date | Date of first distribution |
|---|---|---|---|---|
| NEUPRO 4MG/24H TRANSDERMAL PATCH 1 x 28 | 56666402 | 136496 | 01/11/2019 | 12/04/2018 |
| NEUPRO 4MG/24H TRANSDERMAL PATCH 1 x 28 | 56666403 | 134565 | 01/11/2019 | 12/04/2018 |
| NEUPRO 4MG/24H TRANSDERMAL PATCH 1 x 28 | 56670401 | 134568 | 01/12/2019 | 13/04/2018 |
| NEUPRO 4MG/24H TRANSDERMAL PATCH 1 x 28 | 56679402 | 134567 | 01/01/2020 | 19/03/2018 |
| DUORESP SPIROMAX 160MCG/4.5MCG 1 x 120 | AFB75A | 135975 | 01/04/2020 | 13/04/2018 |
| INCRUSE ELLIPTA 55mcg INHALER 1 x 30 DOSES | R834141 | 134561 | 01/09/2019 | 21/05/2018 |
Appendix 3: Table of Products / Batches Doncaster Pharmaceuticals Group Ltd
Neupro 4mg/24 hr Transdermal Patch 1 x 28 EU/1/05/331/005
| Italian Batch Number | Doncaster Batch Number | Expiry Date | First Distributed | ||
| # 56688403 | 56688403/0079 | Feb 2020 | 06/08/2018 | ||
| # 56679402 | 56679402/0079 | Jan 2020 | 17/08/2018 | ||
| # 56649401 | 56649401/0079 | Aug 2019 | 22/08/2018 | ||
| # 56695404 | 56695404/0079 | Mar 2020 | 10/09/2018 |
Appendix 4: Table of Products / Batches Drugsrus Ltd / P.I.E. Pharma Ltd
Neupro 4mg/24 hr Transdermal Patch 1 x 28 EU/1/05/331/005
- Italian Batch Number: 56695404
- Drugsus Batch Number: C23275
- Expiry Date: Mar 2020
- First Distributed: 08/04/2019