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Class 2 FMD Medicines Recall, Parallel Distributed Medicines, Multiple Products, EL (20)A/45

Medicines Healthcare Products Regulatory Agency

September 16
13:00 2020

MDR Number

MDR 118-08/20

Company Names

Beachcourse Limited, Orifarm A/S, OPD Laboratories Limited, Strathclyde Pharmaceuticals Limited, Quadrant Pharmaceuticals Limited and Lexon UK

Product description

Table 1: Affected products / Beachcourse Limited

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

Table 2: Affected products / Orifarm A/S

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

Table 3: Affected products / OPD Laboratories Limited

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

Table 4: Affected products / Strathclyde Pharmaceuticals Limited (repacked by Munro Wholesale Medical Supplies Limited)

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

Table 5: Affected products / Quadrant Pharmaceuticals Limited (repacked by Maxearn Limited)

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

Table 6: Affected products / Lexon (UK) Limited

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

Brief description of the problem

We 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 above. 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.

Advice for wholesalers

Please quarantine all stock from the affected batches which are parallel distributed or repacked by the named companies detailed in the tables above, and return the medicines (including those returned from pharmacies) to the named parallel distributor/repacker for further instructions. The name of the parallel distributor/repacker can be found on the product packaging.

Further Information

BeachCourse Limited

For all enquiries please contact:

Julio Iglesias (Site Manager) on 02088969075 or email at julio.bcourse@btconnect.com.

Orifarm A/S

For all enquiries please contact:

Paul Tobin (Responsible Person) on 07583577513 or email at paul.tobin@orifarm.com.

Steven Cross (UK Parallel Import Sales Manager) on 07498975920 or email at steven.cross@orifarm.com.

OPD Laboratories Limited

For all enquiries please contact:

Vasanth Samson (Quality Assurance Manager/Responsible Person) on 01923332773 or email at 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) on 07838038063 or email at abdul.butt@maxearn.co.uk.

Lexon (UK) Limited

For all enquiries please contact:

Yogesh Patel at yogesh.patel@lexonuk.com

Recipients of this Drug Alert should bring it to the attention of re

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