U.K. regulators have decided it is best after all if Indian drugmaker Wockhardt recalls a handful of drugs manufactured at its Chikalthana facility--earlier this week, the agency banned the company from exporting most of its drugs to Europe. When the Medicines and Healthcare products Regulatory Agency (MHRA) initiated the ban this week, it initially said no drugs were being recalled.
The 5 drugs include Type 2 diabetes treatment gliclazide and a number of drugs for pain, the MHRA said in a release today. In addition to gliclazide, they include amiloride HCl, two strengths of clarithromycin, quinine sulphate and tamsulosin (Pinexel). The agency said there were no indications the drugs posed any kind of health threat and that consumers who had the drugs could continue to take them. It said the problems identified at the plant related to "poor record keeping relating to the manufacture and testing of the medicines made at the site, and inadequate validation and production controls for medicines." It pointed out the plant is being allowed to continue to manufacture 10 drugs for the EU market because regulators determined there may not be adequate alternatives for patients.
The action by U.K. regulators this week against Wockhardt's plant in Chikalthana came after the U.K. and the U.S. both banned products from a plant in Waluj earlier in the year. The MHRA had insisted Wockhardt recall 16 drugs when the Waluj plant was cited.
The FDA followed its ban of Wockhardt's Waluj site with a warning letter citing it for a variety of manufacturing and sanitation issues. It said that quality-assurance personnel tried to hide records of batch failures and to destroy samples that inspectors wanted to examine. Inspectors also found leaking toilets and puddle of urine in a bathroom near a sterile manufacturing area. That plant has an oral solid unit and two injectable units. The company told investors that the FDA is allowing it to continue to import its enalapril product, a generic of the blood pressure med Vasotec, that it manufactures there.
In a briefing with investors in August, Wockhardt acknowledged that FDA inspectors also identified problems during its own inspection of the Chikalthana plant. The FDA has yet to publicize what it found at that facility.