Recall: PACIFIC ATENOLOL (Atenolol) 50mg, 100mg

Media Release 27th May 2010
Issued by Mylan New Zealand

Medicine recall: PACIFIC ATENOLOL (Atenolol) 50mg and 100mg Tablets

Mylan New Zealand Limited, following consultation with Medsafe, Ministry of Health, is recalling all Pacific Atenolol 50mg and 100mg tablets, which are manufactured by IPCA Laboratories Limited and marketed by Mylan New Zealand.

Pacific Atenolol tablets are used to treat various heart conditions including high blood pressure, irregular heartbeats and to prevent angina (chest pain). Atenolol belongs to a group of medicines known as beta-blockers.

This recall is being initiated after overweight and underweight tablets were identified. The tablets are visually larger or smaller in size and, as a result, contain a higher or lower dose of the medicine, respectively.

Consumers taking Pacific Atenolol tablets should:

1. Return all Pacific Atenolol tablets to their pharmacy as soon as possible (including any 50mg tablets recently replaced in the previous recall) for a free replacement with a different brand of atenolol tablets.
2. Continue to take their medicine until they have an opportunity to visit the pharmacy. However, they should not take a larger or smaller tablet if one is found.
3. Contact their doctor immediately if any ill effects are noticed.

Mylan NZ has worked with Medsafe to urgently obtain an alternative supply of approved product from a different source to ensure ongoing availability of this medicine.

The replacement atenolol tablets are manufactured by Mylan Pharmaceuticals Inc. in the USA, where they have been marketed for more than 15 years. The replacement tablets are white in colour whereas the recalled Pacific Atenolol tablets are orange in colour. For further product information refer to the Atenolol USP Data Sheet on the Medsafe website at www.medsafe.govt.nz.

Pharmacies are being restocked with the replacement product by urgent courier delivery and all pharmacies should have replacement stock by close of business on Friday 28 May.

If patients or medical professionals require any additional information, they can contact Mylan New Zealand on 0800 200 273.

Mylan New Zealand Limited
Mylan New Zealand Limited (formerly Pacific Pharmaceuticals) is based in Auckland and specialises in generic medicines. Mylan’s Asia-Pacific presence includes market leading positions in New Zealand and Australia.

Mylan Inc., headquartered in the US, ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world’s largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information, please visit www.mylan.com.

ENDS

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