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.
