Routine inspection found low risk of contamination because of poor cleaning practices and defects in building fabric and the ventilation systems
The UK’s drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued a ‘precautionary recall’ of 16 prescription-only medicines in a variety of strengths made by Wockhardt after it identified ‘manufacturing deficiencies’ at the Indian firm’s Waluj plant.
The MHRA said there is no evidence that the products are defective and patients do not need to return their medicines, pharmacies, dispensing clinics and wholesalers have been asked to return them.
The medicines affected include treatments for infections, high blood pressure, diabetes, epilepsy, depression, schizophrenia, Parkinson’s disease, dementia in Alzheimer’s patients and thyroid conditions.
‘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,’ the MHRA said.
During a routine inspection of the Waluj plant in March, the MHRA found a low risk of cross-contamination because of poor cleaning practices and defects in building fabric and the ventilation systems. 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.