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

Medicines from the listed parallel distributors are being recalled due to concerns that the supply chain may have been compromised and the origins of the products are unknown

From:: Medicines and Healthcare products Regulatory Agency
Published: 16 September 2020

Message type:: Medicines recall/notification
Medical specialty:: Pharmacy
Issued:: 16 September 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/1/08/470/005	14 or 56	291621	09/2024
Vimpat 100mg Tablets	EU/1/08/470/004 or EU/1/08/470/005	14 or 56	295851	12/2024
Vimpat 100mg Tablets	EU/1/08/470/004 or EU/1/08/470/005	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/1/08/470/005	14 or 56	258582	06/2023
Vimpat 100mg Tablets	EU/1/08/470/004 or EU/1/08/470/005	14 or 56	259249	06/2023
Vimpat 100mg Tablets	EU/1/08/470/004 or EU/1/08/470/005	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/1/08/470/005	14 or 56	267525	10/2023
Vimpat 100mg Tablets	EU/1/08/470/004 or EU/1/08/470/005	14 or 56	267862	08/2023
Vimpat 100mg Tablets	EU/1/08/470/004 or EU/1/08/470/005	14 or 56	267863	10/2023
Vimpat 100mg Tablets	EU/1/08/470/004 or EU/1/08/470/005	14 or 56	263100	08/2023
Vimpat 100mg Tablets	EU/1/08/470/004 or EU/1/08/470/005	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.