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Press release: MHRA issues precautionary recall of medicines

Press release

Date: 11 July 2013
Time: 13:00
Subject: MHRA issues precautionary recall of medicines manufactured by Wockhardt Ltd
Contact: Press Office 020 3080 7651
or press.office@mhra.gsi.gov.uk
Out-of-hours 07770 446 189

Pharmacies, dispensing clinics and wholesalers were today asked to return 16 different prescription only medicines in a variety of strengths made by Wockhardt Ltd following a precautionary recall by the Medicines and Healthcare products Regulatory Agency (MHRA). This follows manufacturing deficiencies identified by the MHRA at Wockhardt’s Waluj site in India.

The medicines affected by the precautionary recall include those used for the treatment of infections, high blood pressure, diabetes, epilepsy, depression, schizophrenia, Parkinson’s disease, dementia in Alzheimer’s patients and thyroid conditions.

Patients do not need to return their medicines because there is no evidence that the medicines affected by the precautionary recall in the UK are defective. Therefore, it’s important that people continue to take their medicines as prescribed.

This is not a patient level recall because although the medicines that are affected have not been manufactured to Good Manufacturing Practice (GMP) standards, there is no evidence of a patient safety risk from medicines that have been sold in the UK. However, the MHRA has to act in the interests of public health as poor manufacturing standards cannot be allowed to continue.

The deficiencies identified by the MHRA during a routine inspection in March included a low risk of cross-contamination because of poor cleaning practices and defects in building fabric and the ventilation systems at the site. There was also evidence of forged documents relating to staff training records that had been rewritten. The MHRA is working with Wockhardt and other international regulators to resolve these issues.

Gerald Heddell, the 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.”
The medicines that are involved in the recall are available for patients from alternative manufacturers in most cases, either in equivalent strengths or varying strengths. Where there are no alternative manufacturers of the same medicines, substitutes are available and these should be selected by a healthcare professional.

The Department of Health is working closely with the companies concerned to help ensure that patients are able to get their medicines when they need them.

Notes to Editor

1. Class 2 Drug Alert (Action within 48 Hours): Multiple products - Wockhardt UK Limited (EL (13)A/19) - This includes a list of all the medicines that are affected by the precautionary recall.

2. Class 2 Medicines recall (Action within 48 Hours): Erythromycin Oral Suspension - Pinewood Laboratories Limited (EL (13)A/20)

3. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.

http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON296424
Page last modified: 11 July 2013