MHRA recalls five Wockhardt medicines
pharmafile | October 18, 2013 | News story | Manufacturing and Production | FDA, GMP, MHRA, Violations, Wockhardt, recall
The UK drugs regulator has recalled five more generic medicines made by Indian drugmaker Wockhardt after an inspection uncovered quality deficiencies at the facility where they are made.
The Medicines and Healthcare products Regulatory Agency (MHRA) took the action after the inspection of Wockhardt’s plant in Chikalthana, Aurangabad, resulted in its Good Manufacturing Practice (GMP) certification being withdrawn.
The MHRA has provided the Chikalthana facility with a restricted GMP certificate, effectively meaning it will only accept ten critical medicines made at the plant, with a ban on all imports of other medicines into Europe.
The problems identified at the plant include “poor record keeping relating to the manufacture and testing of the medicines made at the site,” as well as “inadequate validation and production controls”, according to the agency.
The five recalled medicines include diuretic amiloride (5mg tablets), antibiotic clarithromycin (250 and 500mg tablets), diabetes treatment gliclazide (80mg tablets), antimalarial quinine sulphate (300mg tablets) and tamsulosin (400mcg capsules) for prostate gland enlargement.
In a statement the MHRA said: “People 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.”
This is the second Wockhardt infringement to be brought into the regulatory spotlight in recent months. In July the MHRA issued a precautionary (class II) recall of 16 prescription-only medicines manufactured by Wockhardt at its Waluj plant in Aurangabad, shortly after joining the FDA in imposing an import ban on drugs made there.
That action was followed by an FDA warning letter which said that staff at Waluj had repeatedly tried to interfere with FDA officials auditing the site, and tried to hide batch records.
In one incident a quality control analysts dumped unlabelled and partially labelled products down a sink when asked what they contained, and in another inspectors were prevented from accessing an aseptic filling line producing product for export to the US.
The letter also points to failures in documentation and record-keeping and hygiene issues, including inadequate drainage in a washroom just six metres from the gowning area serving the sterile formulation manufacturing area, with puddles of stagnant urine observed near an open drain.
Phil Taylor
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