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 have been re-labelled or repackaged in Kosei Pharma UK Ltd, MPT Pharma Ltd, Drugsrus and Doncaster Pharmaceuticals labelling.

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:

  • 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.

  • 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.

  • 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.

  • 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 Drugsrus Batch Number Expiry Date First Distributed
56695404 C23275 Mar 2020 08/04/2019
Published 25 July 2019