The medicines are considered legitimate but have been removed from the supply chain of regulated drugs during distribution and subsequently reintroduced. This means that correct transport and storage conditions cannot be guaranteed during this period and, although unlikely, could affect their effectiveness.
The medicines are stable at room temperature and there is no evidence that they have been tampered with. This means that the risk that these medicines are not fully effective is greatly reduced or negligible. Therefore patients must continue to take their medication.
Patients can check their medications by looking for the affected lot numbers on the packages labeled B & S Healthcare. The medicines concerned are in the original Italian packaging with the UK manufacturer's label, B & S Healthcare. This recall only applies to products labeled B & S Healthcare.
The Medical and Health Products Regulatory Agency (MHRA) has undertaken a medical evaluation of the products to determine if there is any risk to patients. As a precautionary measure, three medicines are recalled at the patient level because in the unlikely event that these products are not fully effective there is a potential risk to patient safety. For these three particular medicines, while the probability that their effectiveness is compromised is low (because they are legitimate stable drugs), the consequences of a lack of effectiveness could be serious, which is why they are recalled by patients.
If patients have any of these affected products, they should continue to take their medicines and contact the general practitioner to arrange a new prescription. Once they have a new prescription, patients must return the affected lots to their pharmacist.
As a precaution, other affected medicines are also referred to at the pharmacy level. Once again, patients must continue to take their medicines. If they have one of these affected products, they do not need to arrange a new prescription, but if they have questions they should talk to their family doctor or health care professional. These drugs are for chronic obstructive pulmonary disease (COPD) (Spiriva inhalation powder, Inhaler Incruse, Seebri Breezhaler), psoriasis (Dovobet Gel) and high cholesterol (Provisacor (Crestor)).
B & S Healthcare is making a recall and the UK drug regulator, MHRA, today issued a notice for pharmacies.
Pharmacies should check the packages involved in the B & S Healthcare labeling, place them in quarantine and return them to their supplier.
Dr. Samantha Atkinson, director of the Inspection, Application and Standard Division of the MHRA, said:
Ensuring that medicines and their families are acceptable is acceptably safe and effective is the main role of MHRA and is our top priority.
When we are aware of the potential risks to the security of the supply chain, the MHRA intervenes to protect the public.
We constantly strive to ensure that the UK's regulated supply chain remains one of the safest in the world.
The retreat is underway in an ongoing MHRA investigation.
The medicines were imported in parallel from the United Kingdom by B & S Healthcare from Italy and were re-labeled in the B & S Healthcare labeling. The same batches of products may have been lawfully imported into the UK by other importers in parallel. Only the B & S Healthcare labeling packages are affected by the recall.
In the United Kingdom, the parallel import licensing scheme allows you to sell medicines authorized in another EU Member State in the UK, provided that the imported product has no therapeutic difference compared to the same UK product and as long as that the parallel importer has an appropriate license from the MHRA.
MHRA works with industry and other regulators around the world to track down and prosecute criminals who endanger public safety by selling drugs illegally. In the year 2018/19 we had eight successful criminal proceedings, with 17 defendants convicted and sentenced, often with prison sentences. We have also obtained confiscation orders for over 450,000 pounds.
MHRA is responsible for regulating all medicines and medical devices in the UK. At the base of all our work there are rigorous and fact-based judgments to ensure that the benefits justify any risk. The MHRA is a center of the Medical and Sanitary Product Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Practical Clinical Research DataLink (CPRD). The MHRA is an executive agency of the Department of Health and Social Care (DHSC).
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