15 Oct 2010

Overseas drug factory audited by Medsafe

3:12 pm on 15 October 2010

Medsafe officials have been sent to India to audit a drug manufacturing factory after a spate of recalls of prescribed drugs this year.

The independent audit of an overseas plant is the first such inspection in nearly two decades, says the Government.

In one of the recall cases, Medsafe, the Ministry of Health's drug regulatory agency, was so concerned that it conducted an independent audit of a manufacturing plant in India.

The case involved two recalls of the drug Pacific Atenolol, which is used to treat heart conditions such as high blood pressure and irregular heartbeats and to prevent angina.

The drug, distributed by Mylan New Zealand Ltd, was recalled twice in May as samples were found to be either too big or too small.

Following the visit to the plant, Medsafe has confirmed it is confident in the manufacturing processes.

The company has defended its manufacturing processes, saying the quality and safety of its products are its first priority.