Medicine recall: Respigen 100 microgram aerosol

Media Release 30th March 2010
Issued by Mylan New Zealand

Medicine recall: Respigen (salbutamol) 100 microgram Inhalation aerosol

Mylan New Zealand, in consultation with Medsafe, is recalling one batch of Respigen (salbutamol) 100 microgram Inhalation aerosol (batch number 9F282A) which is manufactured by Pharmaserve NW in the UK and marketed by Mylan New Zealand.
The affected batch expires in May 2012. (Exp 05/2012).

No other batch of Respigen Inhalation aerosol distributed by Mylan is affected by this recall.

Respigen Inhalation aerosol is a blue, reliever-type inhaler, containing salbutamol, used to control the symptoms of asthma.

Although most patients may not be affected, Mylan New Zealand is undertaking this recall as a precautionary measure after quality control procedures identified that a small number of inhalers from this batch have quantities of salbutamol that are out of specification. As a consequence, the inhaler may deliver doses of salbutamol that are inconsistent with that stated on the label.

Consumers using Respigen Inhalation aerosols should:
1. Check if the batch is 9F282A. The batch number can be found either on the base of the box or by removing the silver can from inside the blue plastic cover.
2. Return inhalers of batch 9F282A to a pharmacy as soon as possible for a free replacement.
3. Continue to use their inhaler if they need it prior to obtaining a replacement. Follow their asthma management plan if their symptoms are not controlled, which may include increasing the dose or frequency of use of Respigen Inhalation aerosol.
4. Contact their health care professional if they have any concerns about the management of their asthma.

“Because product quality and patient safety always come first at Mylan, we have ongoing quality control measures in place that monitor the products we manufacture and those that we market,” Mylan New Zealand Managing Director, Mr Lloyd Price, said. “Through these stringent procedures, we were able to determine that this particular batch of Respigen was out of specification, and we took immediate steps to bring it to Medsafe’s attention and resolve the issue.”

If patients or medical professionals require any additional information, they can contact Mylan New Zealand on 0800 579 811

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About Respigen
The Respigen Inhalation aerosol is a medicine approved for distribution in New Zealand and used in the treatment of asthma. The inhaler contains salbutamol which acts directly on the muscles in the airways of the lung causing the muscles to relax. It is used to relieve the symptoms of asthma.

Respigen Inhalation aerosol contains a CFC-free propellant and has been available in New Zealand since May 2008. It is manufactured for Mylan New Zealand by a third party in the UK.

Mylan New Zealand Ltd
Mylan New Zealand Ltd (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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