Print Page

Medicine recalls

 
The United Kingdom: Class 2 Falsified Medicines Directive (FMD) Medicines Recall, Parallel distributed medicines, multiple products
 
Medicines and Healthcare products Regulatory Agency (MHRA) announces that it has been notified of an issue whereby several affected batches of the following products from the 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. The affected products are:
Beachcourse Limited
- Neupro 4mg/24 hour Transdermal Patches (batch number: 58017123)

Orifarm A/S
- Vimpat 100mg Tablets (batch number: 291621, 295851, 296212)

OPD Laboratories Limited
- Vimpat 100mg Tablets (batch number: 258582, 259249, 267862)

Strathclyde Pharmaceuticals Limited (repacked by Munro Wholesale Medical Supplies Limited)
- Vimpat 100mg Tablets (batch number: 267525, 267862, 267863, 263100, 258582)
- Neupro 4mg/24 hour Transdermal Patches (batch number: 58033101)

Quadrant Pharmaceuticals Limited (repacked by Maxearn Limited)
- Neupro 4mg/24 hour Transdermal Patches (batch number: 58033101)

Lexon (UK) Limited
- Neupro 4mg/24 hour Transdermal Patches (batch number: 58017123, 58030102, 58033103, 58037101)

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 United Kingdom market. There is no suggestion at this time that any of the United Kingdom 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.

Please refer to the following website in MHRA for details: http://www.gov.uk/drug-device-alerts/class-2-fmd-medicines-recall-parallel-distributed-medicines-multiple-products-el-20-a-45

In Hong Kong, Neupro Transdermal Patch 4mg/24h (HK-55446) and Vimpat Tab 100mg (HK-61176) are pharmaceutical products registered by UCB Pharma (Hong Kong) Limited (UCB Pharma), and are prescription-only medicines. As confirmed with UCB Pharma, the affected batches have not been imported into Hong Kong.

Ends/Thursday, Sep 17, 2020
Issued at HKT 16:30
 
 
back