British drug regulator recalls 16 Wockhardt drugs
11 July 2013
The British drug regulator today issued a precautionary recall of 16 prescription-only medicines made by Indian Pharmaceutical company Wockhardt Ltd after it found deficiencies in manufacturing procedures at the its plant in Waluj in Aurangabad.
Medicines and Healthcare Products Regulatory Agency (MHRA) said that it would recall the 16 prescription medicines, including 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.
However, the MHRA said that patients do not need to return their medicines because there is no evidence that the medicines affected by the precautionary recall are defective, and that they should continue to take their medicines as prescribed.
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."
This is not a patient-level recall because although the medicines that are affected have not been manufactured according to Good Manufacturing Practice (GMP) standards, there is no evidence of a patient safety risk from medicines that have been sold in the UK.
Heddel said, "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."
The MHRA said that it has to act in the interests of public health as poor manufacturing standards cannot be allowed to continue.
The regulator said that a routine inspection in March revealed deficiencies in manufacturing, including a low-risk of cross-contamination because of poor cleaning practices and defects in building fabric and the ventilation systems at the site.
The MHRA is working with Wockhardt and other international regulators to resolve these issues.