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Sixteen prescription drugs made in India recalled by UK watchdog

12 July 2013

medcines

Sixteen prescription drugs produced at an Indian factory that failed a routine inspection have been recalled by the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

The agency watchdog has asked pharmaceutical companies to return stock made by Wockhardt at its Waluj site.

These include diabetes drug Metformin; Atenolol, which is taken for high blood pressure and angina; the schizophrenia drug Risperidone; Pramipexole, taken for Parkinson's disease; and Clopidogrel for blood clots.

Erythromycin, an antibiotic given to children, is also being recalled by the agency after it was made at the Waluj site but imported by a separate company,

The MHRA have stressed that other versions of most of the recalled drugs are available from several pharmaceutical companies and that there is no evidence of a risk to patient safety, saying the recall is precautionary only.

"An inspection at the Waluj factory in March revealed a low risk of cross-contamination due to poor cleaning practices and defects in the building fabric and ventilation systems on the site."

An inspection at the Waluj factory in March revealed a low risk of cross-contamination due to poor cleaning practices and defects in the building fabric and ventilation systems on the site.

Inspectors also found evidence of forged documents relating to staff training records that had been re-written.

The MHRA said it is working with Wockhardt and other international regulators to resolve the issue.

The MHRA's director of inspection, enforcement and standards Gerald Heddell, said: "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."


Image: Atenolol, which is taken for high blood pressure and angina, is one of the drugs recalled. Photo: courtesy of Cristian Bender.