The attached alert document has been updated to rectify an error in the EU ref number for
Vimpat 100mg Tablets in the alert (specifically in Tables 2, 3 and 4 – the
latter EU ref should state EU/1/08/470/005
and not EU/1/05/331/005).
We have been notified of an issue whereby several affected batches of the products from several 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 alert. The name of the parallel distributor/repacker can be found on the product packaging. If you have any affected stock, please return if 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 alert, 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.
Full details of the drug alert are included in the attached PDF file. Please forward to listed recipients. This information is also published on the MHRA website https://www.gov.uk/drug-devices-alerts
Falsified Medicines Directive (FMD) 2011/62/EU introduced new requirements to enhance the security of the European supply chain. Where the MHRA has identified risks to the security of the supply chain, FMD Alerts will be issued. For further information about FMD and safety features, please see this link on GOV.UK.