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Two Site Audits Followed Drug Recalls - Medsafe

Fuseworks Media
Fuseworks Media
Two Site Audits Followed Drug Recalls - Medsafe

The Ministry of Health's medicine regulatory arm Medsafe says there have been two site audits following three of the the five consumer level medicine recalls this year.

This number of recalls is higher than the usual number (averaging approximately 3 per year over the past 10 years, with none occurring since mid 2007), Derek Fitzgerald, Medsafe's Manager of Compliance Management said today.

In New Zealand, Medsafe audited a New Zealand manufacturer - Douglas Pharmaceuticals in Auckland - as well as the Indian based contract manufacturer IPCA Laboratories based near Mumbai.

Medsafe says each of the audits determined that the sites complied to a satisfactory level with Good Manufacturing Practice (GMP) and that the companies had taken appropriate action to identify the cause of the recalls and institute acceptable solutions. There were no significant concerns at the plants.

Overseas audits of medicine manufacturers carried out by Medsafe are relatively uncommon.

The five day audit in August of the Athal plant (170 km north of Mumbai) by two Medsafe staff was thorough and gave assurance that the plant which had been involved in two of the five recalls of two different strengths of the heart medication atenolol was operating to a satisfactory standard.

Medsafe believes the current medicines on the New Zealand market from the Indian manufacturer are as safe as any others currently available.


In January this year, Marevan 3mg tablets were recalled because a manufacturing error resulted in some high strength tablets being inadvertently incorporated in a batch. Marevan is an anticoagulant used for blood clotting disorders. Marketed by Glaxo SmithKline.

In March, Respigen inhalers were recalled because a manufacturing error led to variability in doses in some of the inhalers. Respigen is used in the treatment of asthma. Marketed by Mylan NZ Ltd.

In May:

* one batch of Pacific Atenolol 50mg tablets was recalled (as some tablets were overweight). Atenolol is used to treat various heart conditions including high blood pressure, irregular heartbeats and to prevent angina (chest pain). Marketed by Mylan NZ Ltd.

* all batches of Pacific Atenolol 50mg and 100mg tablets were recalled (due to dose variability). Marketed by Mylan NZ Ltd. In August, a Glucagen hypokit injection was recalled because some cracks in the glass syringe containing the diluent (diluting solution) could cause leaks or contamination. Glucagen hypokit is used by diabetics as an emergency treatment of hypoglycaemia. Marketed by Novo Nordisk NZ Ltd.

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