UK drug regulator, Medicines and Healthcare products Regulatory Agency (MHRA) today said it has issued a precautionary recall for sixteen medicines made by Wockhardt at its Waluj unit due to manufacturing shortcomings.
“This follows manufacturing deficiencies identified by the MHRA at Wockhardt’s Waluj site in India,” the MHRA said in a statement.
The sixteen ‘prescription only medicines’ 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, it added.
The Waluj facility makes injectables and solid dosages.
MHRA’s Director of Inspection Enforcement and Standards Gerald Heddell 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 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.
“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,” it added.
There was also evidence of forged documents relating to staff training records that had been rewritten, the MHRA said.
The UK drug regulator said it is working with Wockhardt and other international regulators to resolve these issues.
Last week, Wockhardt chairman Habil Khorakiwala had said: “We have been issued an alert by MHRA. We would be shifting the manufacturing of products (from Waluj) to another facility, thereby minimising the impact of the alert.”
Earlier in May, an import alert was also issued by the US health regulator on the same manufacturing facility. The USFDA has put an import alert on one of the company facilities, at Waluj, near Aurangabad. The company estimates that it would impact our business by $ 100 million on an annualised basis, Khorakiwala had said.
Shares of Wockhardt Ltd today closed at Rs 937.95 per scrip on the BSE, down 2.40 per cent from its previous close.