Media release from Mylan New Zealand Tuesday 30 March 2010, 4:40PM
Media release from Mylan New Zealand
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.