Regulatory Focus™ > News Articles > MHRA Issues Precautionary Recall of 16 Drugs Manufactured by Wockhardt

MHRA Issues Precautionary Recall of 16 Drugs Manufactured by Wockhardt

Posted 11 July 2013 | By Louise Zornoza 

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a precautionary recall of medicines manufactured by Wockhardt Ltd. following the discovery of manufacturing deficiencies at the company's Waluj site in India. The products affected by the recall include drugs used for the treatment of infections, high blood pressure, diabetes, epilepsy, depression, schizophrenia, Parkinson's disease, dementia in Alzheimer's patients and thyroid conditions.

The deficiencies were identified by the MHRA during a routine inspection in March 2013.  They included a low risk of cross-contamination due to poor cleaning practices and building and ventilation defects.  The agency also found evidence of forged documents relating to staff training records.

The MHRA opted not to initiate a patient level recall because although the affected drugs were not manufactured to Good Manufacturing Practice (GMP) standards, there is no evidence risk to patients from those sold in the UK.

Commenting on the decision, MHRA Director of Inspection, Enforcement and Standards Gerald Heddell said the recall was "precautionary" in nature. 

"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," she said. "All batches of medicines manufactured outside the EU 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."

MHRA Statement on Wockhardt

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Tags: UK, EU

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