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
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.
Further Information
BeachCourse Limited
For all enquiries please contact:
Julio Iglesias (Site Manager) on 02088969075 or email at [email protected].
Orifarm A/S
For all enquiries please contact:
Paul Tobin (Responsible Person) on 07583577513 or email at [email protected].
Steven Cross (UK Parallel Import Sales Manager) on 07498975920 or email at [email protected].
OPD Laboratories Limited
For all enquiries please contact:
Vasanth Samson (Quality Assurance Manager/Responsible Person) on 01923332773 or email at [email protected].
Strathclyde Pharmaceuticals Limited
For all enquiries please contact:
Derek Cochrane (QA Manager) at [email protected].
Quadrant Pharmaceuticals Limited
For all enquiries please contact:
Abdul Butt (Director, Quality & QP) on 07838038063 or email at [email protected].
Lexon (UK) Limited
For all enquiries please contact:
Yogesh Patel at [email protected]
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this notice.
NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
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