Class 2 FMD Medicines Recall – Parallel Distributed Medicines, Multiple Products

Class 2 FMD Medicines Recall – Parallel Distributed Medicines, Multiple Products

September 16, 2020

MDR number: 111-08/20

Drug alert number: EL (20)A/45

Date issued: 16 September 2020

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 2 FMD Drug Alert for:

Beachcourse Limited
Please see table below for list of products and batch numbers 

Product EU ref number Pack Size Batch Number Expiry Date
Neupro 4mg/24 hour Transdermal Patches EU/1/05/331/004
or EU/1/05/331/005
7 or 28 58017123 10/2021

Orifarm A/S
Please see table below for list of products and batch numbers

Product EU ref number Pack Size Batch Number Expiry Date
Vimpat 100mg Tablets EU/1/08/470/004
or EU/1/05/331/005
14 or 56 291621 09/2024
Vimpat 100mg Tablets EU/1/08/470/004
or EU/1/05/331/005
14 or 56 295851 12/2024
Vimpat 100mg Tablets EU/1/08/470/004
or EU/1/05/331/005
14 or 56 296212 10/2024

OPD Laboratories Limited
Please see table below for list of products and batch numbers

Product EU ref number Pack Size Batch Number Expiry Date
Vimpat 100mg Tablets EU/1/08/470/004
or EU/1/05/331/005
14 or 56 258582 06/2023
Vimpat 100mg Tablets EU/1/08/470/004
or EU/1/05/331/005
14 or 56 259249 06/2023
Vimpat 100mg Tablets EU/1/08/470/004
or EU/1/05/331/005
14 or 56 267862 08/2023

Strathclyde Pharmaceuticals Limited
Please see table below for list of products and batch numbers

Product EU ref number Pack Size Batch Number Expiry Date
Vimpat 100mg Tablets EU/1/08/470/004
or EU/1/05/331/005
14 or 56 267525 10/2023
Vimpat 100mg Tablets EU/1/08/470/004 or EU/1/05/331/005 14 or 56 267862 08/2023
Vimpat 100mg Tablets EU/1/08/470/004
or EU/1/05/331/005
14 or 56 267863 10/2023
Vimpat 100mg Tablets EU/1/08/470/004
or EU/1/05/331/005
14 or 56 263100 08/2023
Vimpat 100mg Tablets EU/1/08/470/004
or EU/1/05/331/005
14 or 56 258582 06/2023
Neupro 4mg/24 hour Transdermal Patches EU/1/05/331/004
or EU/1/05/331/005
7 or 28 58033101 03/2022

Quadrant Pharmaceuticals Limited
Please see table below for list of products and batch numbers

Product EU ref number Pack Size Batch Number Expiry Date
Neupro 4mg/24 hour Transdermal Patches EU/1/05/331/004
or EU/1/05/331/005
7 or 28 58033101 03/2022

Lexon (UK) Limited
Please see table below for list of products and batch numbers

Product EU ref number Pack Size Batch Number Expiry Date
Neupro 4mg/24 hour Transdermal Patches EU/1/05/331/004
or EU/1/05/331/005
7 or 28 58017123 10/2021
Neupro 4mg/24 hour Transdermal Patches EU/1/05/331/004
or EU/1/05/331/005
7 or 28 58030102 01/2022
Neupro 4mg/24 hour Transdermal Patches EU/1/05/331/004
or EU/1/05/331/005
7 or 28 58033103 03/2022
Neupro 4mg/24 hour Transdermal Patches EU/1/05/331/004
or EU/1/05/331/005
7 or 28 58037101 04/2022

MHRA have been notified of an issue whereby several affected batches of the products from the above parallel distributors (repackers) have been found to have mismatched unique pack numbers on the bollino label (a security and safety feature on the outer packaging). The unique pack numbers on the bollino label should be identical. Based on the information provided to the MHRA, a wholesaler in Italy has purchased stock from an unauthorised wholesaler. Some of these packs have bollino labels which contain mismatched unique pack numbers.

It is known that a number of parallel distributors have purchased the affected batches and these have been distributed to the UK market. There is no suggestion at this time that any of the UK parallel distributors have knowingly purchased or onward supplied medicines that they knew or believed to be falsified. However, parallel distributors who have procured the affected batches are recalling these at pharmacy and wholesaler level due to concerns that the supply chain may have been compromised and the origins of the products are unknown. This case is currently under investigation in collaboration with the Italian authorities – further updates will be published if there are other products which may be impacted.

Advice for healthcare professionals

Please quarantine all stock from the affected batches which are parallel distributed or repacked by the named companies detailed in the tables below. The name of the parallel distributor/repacker can be found on the product packaging. If you have any affected stock, please return it to your supplier.

Company contacts for further information

BeachCourse Limited:
For all enquiries please contact Julio Iglesias (Site Manager) at 02088969075 or email julio.bcourse@btconnect.com

Orifarm A/S
For all enquiries please contact:

OPD Laboratories Limited
For all enquiries please contact Vasanth Samson (Quality Assurance Manager /Responsible Person) at 01923332773 or email vasanth@sigmapl.com

Strathclyde Pharmaceuticals Limited
For all enquiries please contact Derek Cochrane (QA Manager) at dcochrane@munro-group.eu

Quadrant Pharmaceuticals Limited
For all enquiries please contact Abdul Butt (Director, Quality & QP) at 07838038063 or email abdul.butt@maxearn.co.uk

Lexon (UK) Limited
For all enquiries please contact Yogesh Patel at yogesh.patel@lexonuk.com

View the full alert here .

 



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