Medsafe has audited two companies, one at home and one abroad, after drug recalls, the Ministry of Health has revealed.
Medsafe says it audited Auckland-based Douglas Pharmaceuticals, which manufactures Marevan, an anticoagulant used for blood clotting disorders.
The drug is marketed by Glaxo SmithKline.
In January this year, Marevan 3mg tablets were recalled due to a manufacturing error, which meant some high-strength tablets were inadvertently included in a batch.
Medsafe also made a special trip to India to audit contract manufacturer IPCA Laboratories due to two drug recalls in May.
The recalls were for Pacific Atenolol, marketed by Mylan New Zealand, a drug used to treat heart conditions like high blood pressure and irregular heartbeats, and prevent angina.
However, all the audits found the sites satisfactorily complied with good manufacturing practice, Medsafe compliance manager Derek Fitzgerald said.
He said it was uncommon for Medsafe to carry out an overseas audit of a medicine manufacturers.
The five-day audit in August of the Athal plant by two Medsafe staff was "thorough".
Medsafe believed the current medicines on the New Zealand market from the Indian manufacturer were as safe as any others available, he said.
A Mylan spokesman said the incidents demonstrated why consumers "should have every confidence about the strict quality standards applied by both Mylan New Zealand and Medsafe to medicines available in New Zealand".
Mylan recalled the product, manufactured by a third party supplier, because it did not meet its strict quality standards.
"At all times, Mylan New Zealand worked professionally and effectively, and in close consultation with Medsafe, to resolve these matters quickly in the interest of consumer safety and product quality," he said.
Mylan's first priority was always the "quality, safety and efficacy" of its products.
In March, Respigen inhalers, marketed by Mylan, were also recalled because of a manufacturing error, which led to variable doses in some of the inhalers. Respigen is used for the treatment of asthma.
In August, a Glucagen hypokit injection was recalled because some cracks in the glass syringe containing a diluting solution could cause leaks or contamination.
Glucagen hypokit is used by diabetics as an emergency treatment of hypoglycaemia and is marketed by Novo Nordisk New Zealand.











