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MHRA recalls drugs as ‘precautionary measure’

The UK’s drugs regulator has issued a ‘precautionary’ recall of 16 prescription-only drugs of various doses made by Wockhardt Ltd, after manufacturing problems were identified at the site where they are made in India.

The medicines – which include commonly used antimicrobials, antipsychotics, antidepressants and antihypertensives as a well as treatments for Parkinson’s and Alzheimer’s disease – are being recalled from pharmacies only, so patients are being advised to continue to take any of the medicines they already have.

A full list of the recalled drugs is available on the Medicines and Healthcare Products Regulatory Agency (MHRA) website.

The MHRA found a low risk of cross contamination during the manufacturing process at Wockhardt’s site, because of poor cleaning practices and defects in buildings and ventilation at the site.

The agency said in a press statement: ‘This is not a patient level recall because although the medicines that are affected have not been produced to Good Manufacturing Practice [GMP] standards, there is no evidence of a patient safety risk from medicines that have been sold in the UK.’

Gerald Heddell, MHRA’s director of inspection, enforcement and standards, said: ‘This is a precautionary recall. People can be reassured that there is no evidence that medicines made by Wockhardt are defective, so it’s important people continue to take their medicines as prescribed.

‘All batches of medicines manufactured outside the European Union are tested on importation to the UK before they reach patients. However, we have taken this precautionary action because the medicines have not been manufactured to the right regulatory standards.

‘We are working with the Department of Health to ensure that people have access to the medicines they need. Anyone who has questions should speak to their pharmacist or GP.’

Sirjiwan Singh, managing director at Wockhardt UK Ltd, commented: ‘In the latest audit MHRA conducted, they found a certain number of GMP deficiencies. We have already taken action in responding to the deficiencies and have also hired an international consultancy firm.

‘This consultancy has been working with us already for four weeks at the plant and suggested certain actions and we will be reporting on a regular basis to the MHRA about how those improvements are being implemented. I expect the changes will be in place by September and we will be ready for any audit by the MHRA after that.’

He added: ‘The MHRA very clearly advised that this is only a precautionary recall. The products on the market are not defective but they asked us to recall the products as a precautionary measure. So patients need not get concerned about it, and our position is that we have recalled all our stocks from pharmacies and wholesalers and by tomorrow we expect to have received everything.’

MHRA - Class 2 drug alert


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