The U.K. drug regulator Medicines and Healthcare products Regulatory Agency (MHRA), on Thursday, said it had issued a precautionary recall for 16 medicines made by Wockhardt at its Waluj unit due to manufacturing shortcomings.
“This follows manufacturing deficiencies identified by the MHRA at the Wockhardt’s Waluj site in India,” the MHRA said in a statement.
The 16 ‘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.
The 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 U.K., 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 U.K. drug regulator said it was working with Wockhardt and other international regulators to resolve these issues. Shares of Wockhardt on Thursday closed at Rs.937.95 on BSE, down 2.40 per cent from its previous close.
