The Medicines and Healthcare products Regulation Agency (MHRA) has recalled 69 batches of medicines imported from Italy following concerns they were taken out of the regulated supply chain.
The eight affected treatments are for chronic obstructive pulmonary disease (COPD), psoriasis, high cholesterol, Parkinson’s, epilepsy and blood clots.
They left the supply chain during distribution and were later re-introduced prior to being imported into the UK by B & S Healthcare, said the medicines watchdog yesterday (27 June).
B & S Healthcare ‘followed protocol’ and imported the medicines in line with their usual parallel import process, alerting the MHRA on discovery that the medicines were ‘not what they were supposed to be’, an MHRA spokesperson told The Pharmacist.
Only packs re-labelled by B & S Healthcare are affected as the same batches of products may have been parallel imported legitimately into the UK by other importers, the medicines watchdog clarified.
The MHRA said: ‘The correct transport and storage conditions cannot be guaranteed during this period and, while unlikely, could impact their effectiveness.’
Pharmacists should stop dispensing the affected batches of immediately, quarantine them and return all remaining stock to the supplier within 48 hours, the medicines watchdog said.
Patient level recall
The MHRA also warned patients taking the prescription-only medicines for Parkinson’s (Neupro), epilepsy (Vimpat) and blood clots (Clexane) to check whether they have any products from the recalled batches.
Patients are advised to continue taking their medicines and contact their GP practice to arrange a new prescription.
The EU Falsified Medicines Directive (FMD) is a set of pan-European anti-counterfeiting measures that came into force on 9 February.
The affected batches can be viewed here.