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Revised: 28 May 2010

Medicine Recall - Pacific Atenolol (atenolol) 50mg and 100mg tablets

Please attribute this statement to Mr Derek Fitzgerald, Manager, Compliance Management, Medsafe

The Ministry of Health's medicines regulatory arm Medsafe is working closely with the medicine supplier over the recall of all Pacific Atenolol (Atenolol) 50 mg and 100mg tablets, which are used to treat various heart conditions including high blood pressure, irregular heartbeats and to prevent angina (chest pain).

Mylan New Zealand Ltd, which markets this medicine, has issued a recall notice to pharmacies, requesting pharmacists contact their patients. Patients are being asked to return all Pacific Atenolol 50 mg and 100mg tablets to their pharmacy as soon as possible (including any 50mg tablets recently replaced in the recall earlier this month) for a free replacement.

The tablets are being recalled because some tablets have been identified that are visually larger or smaller in size and, as a result, contain a higher or lower dose of the medicine, respectively.

Supplies of replacement Atenolol products manufactured in the US are being sent to pharmacies throughout the country by urgent courier delivery. All pharmacies should have replacement stock by close of business on 28 May 2010. The replacement tablets are white in colour whereas the recalled tablets are orange in colour.

Patients are advised to continue taking their medicine until they have an opportunity to visit their local pharmacy but should not take any tablets that look larger or smaller than usual. Those experiencing any ill effects from taking the medicine should contact their doctor immediately.

Mylan will also place consumer recall notices in newspapers over the next few days.

The latest action follows the recall of one batch of Pacific Atenolol 50mg tablets earlier in May. That recall was initiated after overweight tablets were identified.

Mr Fitzgerald says the recall is being handled by Mylan, and acknowledges that the information may be upsetting for patients, particularly since many of those on these medications are elderly.

"We hope that this will be a straightforward process for most people affected. They'll get a call from their local pharmacy, or be advised through the media, and they can take their Pacific Atenolol tablets to their local pharmacy to get them replaced at no cost."

Patients with any concerns or questions about their medicine are encouraged to discuss these with their doctor or pharmacist. They may also wish to contact the helpline that Mylan set up for individuals wanting more information: 0800 200 273.

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