The medicines are believed to be legitimate but were taken out of the regulated medicines’ supply chain during distribution and later re-introduced. This means that the correct transport and storage conditions cannot be guaranteed during this period and, while unlikely, could impact their effectiveness.
These medicines are stable at room temperature and there is no evidence that they were tampered with. This means that the risk of these medicines not being fully effective is greatly reduced or negligible. Therefore, patients should continue taking their medicine.
Patients can check their medicines by looking for the affected batch numbers on Kosei Pharma UK Ltd, MPT Pharma Ltd, Drugsrus Ltd / P.I.E. Pharma Ltd and Doncaster Pharmaceuticals Group Ltd labelled packs. The affected medicines are in the original Italian packaging with the UK manufacturer’s, Kosei Pharma UK Ltd, MPT Pharma Ltd, Drugsrus Ltd / P.I.E. Pharma Ltd or Doncaster Pharmaceuticals Group Ltd label or has been re-packaged in the UK manufacturers box with this batch number on. This recall relates only to these labelled / repackaged products listed above.
The Medicines and Healthcare products Regulatory Agency (MHRA) has undertaken a medical assessment of the products to determine whether there is any risk to patients. As a precautionary measure, two medicines are being recalled to a patient level because in the very unlikely event that these products are not fully effective there is a potential risk to patient safety. For these two particular medicines, whilst the likelihood of their effectiveness being compromised is low (because they are stable, legitimate medicines), the consequences of a lack of effectiveness could be serious which is why they are being recalled from patients.
If patients have any of these affected products, they should continue taking their medicines and contact their GP practice to arrange a new prescription. Once they have a new prescription, patients should return the affected batches to their pharmacist.
As a precaution, other affected medicines are also being recalled at pharmacy level. Again, patients should continue taking their medicines. If they have any of these affected products, they do not need to arrange a new prescription, but if they have any questions they should speak to their GP or healthcare professional. These medicines are for psoriasis (Dovobet Gel), asthma (Seretide Evohaler 250mcg), asthma and chronic obstructive pulmonary disease (COPD) (DuoResp Spiromax 160mcg/4.5mcg Inhaler) and COPD only (Incruse Ellipta 55mcg Inhaler and Spiriva 18mcg Inhalation Powder Capsules).
Kosei Pharma UK Ltd, MPT Pharma Ltd, Drugsrus Ltd / P.I.E. Pharma Ltd and Doncaster Pharmaceuticals Group Ltd are carrying out a recall and the MHRA has today issued an alert to pharmacies.
Pharmacies should check for the affected packs in Kosei Pharma UK Ltd, MPT Pharma Ltd, Drugsrus Ltd / P.I.E. Pharma Ltd and Doncaster Pharmaceuticals Group Ltd labelling, quarantine and return them to their supplier.
The recall is taking place as part of an ongoing MHRA investigation and follows a recall by B & S Healthcare last month.
Dr Andrew Gray, Deputy Director of the MHRA’s Inspection, Enforcement and Standards Division, said:
“Making sure the medicines people and their families take are acceptably safe and effective is the primary role of the MHRA and is our highest priority.
“When we are made aware of potential risks to the security of the supply chain, the MHRA takes action to protect the public. Following new information, we have issued this further alert to ensure pharmacies have the information they need and to protect public health.
“We continuously strive to ensure the UK’s regulated supply chain remains one of the safest in the world.”