Wockhardt's "poor cleaning practices and forged documents" lead to recall of 16 drugs in the UK

11 July 2013

Pharmacies, clinics and wholesalers in the UK have been asked to return 16 different medications made by Indian drugmaker Wockhardt (BSE: WOCK) as part of a precautionary recall by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

The action was taken after manufacturing deficiencies were identified by the MHRA at Wockhardt’s Waluj site in India. The MHRA said that, although the affected medicines 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.

An MHRA statement said deficiencies identified 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. 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.

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