A drug treatment prescribed for people with type 2 diabetes has been recalled by the Medicines and Healthcare products Regulatory Agency (MHRA) due to problems with the manufacturing process.
Gliclazide, part of the sulfonylurea class of oral hypoglycemics, is one of five medications that have been ordered by the agency to be returned by chemists and wholesalers across the UK.
The drugs are produced by Wockhardt Limited at the company’s manufacturing site in Chikalthana, India. An inspection of this site by the MHRA in July found “manufacturing deficiencies”, including poor record keeping relating to the production and testing of the drugs and inadequate validation and production controls for medicines.
The MHRA said it was working with Wockhardt and other international regulators to resolve these issues, and that for the time being, 10 prescription-only medicines can continue to be made at the Chikalthana site and used in the UK.
It confirmed that despite these issues and concerns over supply, patients currently taking the affected drugs did not need to return them they had as there was no evidence they were defective and no evidence of a patient safety risk.
A recall had to be issued, however, “as poor manufacturing standards means that the quality of medicines is not guaranteed”.
“People can be reassured that there is no evidence of a safety risk from the medicines made at Wockhardt’s Chikalthana site, so it’s important people continue to take their medicines as prescribed,” Gerald Heddell, director of inspectio, enforcement and standards at the MHRA, said.
“We are working with the Department of Health to ensure that people have access to the medicines they need. Anyone who has questions should speak to their pharmacist or GP.”
The affected drugs include Amiloride HCI (5mg tablets), Clarithromycin (250mg and 500mg tablets), Gliclazide (80mg Tablets), Quinine Sulphate (300mg tablets), and Tamsulosin Pinexel (400mcg tablets).

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