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The precautionary recall follows manufacturing deficiencies identified at the site in India.
MHRA issued a precautionary recall of 16 different prescription medicines made by Wockhardt at its Waluj site in India because MHRA identified manufacturing deficiencies during an inspection and noted that the medicines have not been manufactured to GMP standards. The recall was issued to pharmacies, dispensing clinics, and wholesalers, but not patients, MHRA noted in the press release.
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 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.
MHRA indicated that this is not a patient-level recall because, although the medicines that are affected have not been manufactured to GMP standards, there is no evidence of a patient-safety risk from medicines that have been sold in the UK. Poor manufacturing standards cannot be allowed to continue, however, noted the agency.