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The Medicines and Health products Regulatory Agency (MHRA) has issued a Class II falsified medicines directive (FMD) drug alert for a list of products from Beachcourse Limited, Orifarm, OPD Laboratories Limited, Strathclyde Pharmaceuticals Limited, Quadrant Pharmaceuticals Limited, and Lexon (UK) Limited.


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

 

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

 

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

 

Strathclyde Pharmaceuticals 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

 


Quadrant Pharmaceuticals 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

 

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

 

The MHRA has 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,” the MHRA has said.

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 and  further updates will be published if there are other products which may be impacted.

Healthcare professionals have been asked to quarantine all stock from the affected batches which are parallel distributed or repacked by the companies detailed above.

The name of the parallel distributor or repacker can be found on the product packaging.

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