Wockhardt minimizes MHRA precautionary recall hit
This article was originally published in Scrip
The UK MHRA is implementing a precautionary recall of 16 prescription-only medicines in different strengths made by Wockhardt following Good Manufacturing Practice (GMP) deviations at the company's Waluj site in India.
In response, Wockhardt has swung into damage-control mode, suggesting that exports out of the tainted unit constitute less than 5% of its total UK sales and less than 2% of the overall sales of Wockhardt. "The total one-time impact of the UK MHRA recall will be to the tune of £1.5m," the Indian firm added. The MHRA on 11 July said that pharmacies, dispensing clinics and wholesalers had been asked to return certain prescription-only medicines made by Wockhardt, but added that a patient-level recall was not being initiated as there was no evidence of a patient safety risk from medicines that have been sold in the UK.
"Patients do not need to return their medicines because there is no evidence that the medicines affected by the precautionary recall in the UK are defective," a statement from the British regulator said. The medicines that are being recalled include those for the treatment of infections, high blood pressure, diabetes, epilepsy, depression, schizophrenia, Parkinson's disease, dementia in Alzheimer's patients and thyroid conditions.
The Waluj unit was recently issued a statement of non-compliance with GMP by the MHRA and Wockhardt has stopped manufacturing medicines for Europe from this site. The UK MHRA had recently told Scrip that deficiencies identified by it during the routine inspection of the Waluj facility in March included "a risk of cross-contamination" and "evidence of data falsification" in relation to staff training records that were rewritten without authorization (scripintelligence.com 9 July 2013).
The 11 July statement, however, noted a "low risk" of cross-contamination because of poor cleaning practices and defects in building fabric and the ventilation systems at the site. In May this year, the US FDA had issued an import alert against Wockhardt's Waluj unit near Aurangabad (scripintelligence.com, 24 May 2013). The MHRA is also working with Wockhardt and other international regulators including the US FDA to resolve the manufacturing issues so that production can resume.